Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202111591363732 Date of Approval: 16/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID)
Official scientific title Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID)
Brief summary describing the background and objectives of the trial Adapt Out COVID is a master protocol to evaluate the safety and efficacy of investigational agents for the treatment of non-hospitalized adults with COVID-19. The trial is a randomized controlled platform that allows agents to be added and dropped during the course of the study for efficient phase II and phase III testing of new agents within the same trial infrastructure. Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community. Version 7 of the protocol provides for blinded phase II evaluation of an investigational agent for superiority to placebo among participants at lower risk of progression to hospitalization or death, regardless of the mode of administration of the agent. Agents that graduate to phase III after initiation of this protocol version will be evaluated in persons at higher risk for progression to hospitalization or death for non-inferiority to an active comparator, the monoclonal antibody cocktail of casirivimab plus imdevimab (REGEN-COV, Regeneron), which has been shown to be effective in this population in preventing hospitalization or death. When two or more agents are being evaluated in the same phase of the study, the trial design includes sharing of the control group (placebo in phase II and active comparator in phase III) for efficient evaluation of each agent. STUDY OBJECTIVES 1.1 Co-Primary Objectives 1.1.1 Phases II and III: To evaluate safety of the investigational agent. 1.1.2 Phase II: To determine efficacy of the investigational agent to reduce the duration of COVID-19 symptoms through study day 28. 1.1.3 Phase II: To determine the efficacy
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Adapt Out COVID
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 03/01/2022
Actual trial start date
Anticipated date of last follow up 31/12/2023
Actual Last follow-up date 31/12/2023
Anticipated target sample size (number of participants) 1600
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group REGN 10933 and REGN 10987 also known as Casirivimab and imdevimab respectively Active Comparator in Phase III: Casirivimab, 600 mg, and imdevimab, 600 mg, to be administered together as a single infusion as a one-time dose of 1200 mg at Study Entry/Day 0. 5.1.2 Administration Casirivimab and Imdevimab: Prior to administration, attach a polyvinyl chloride (PVC), polyethylene (PE)-lined PVC, or polyurethane (PU) infusion set containing a sterile, in-line or add-on 0.2 micron polyethersulfone (PES) filter and prime the infusion set per institutional procedures. Casirivimab with imdevimab will be administered together as a single IV infusion. The rate of infusion is dependent upon the infusion bag size. For a 50 mL bag, the maximum infusion rate is 180 mL/hour. For a 100 mL, 150 mL, or 250 mL bag, the maximum infusion rate is 310 mL/hr. After the infusion is complete, flush with a sufficient volume of 0.9% Sodium Chloride Injection, USP to ensure full dose administration. Administer the casirivimab and imdevimab solution immediately after preparation. If immediate administration is not possible, store the diluted casirivimab and imdevimab infusion in the refrigerator between 2°C to 8°C for no more than 36 hours or at room temperature up to 25°C for no more than 4 hours, including the infusion time. If refrigerated, allow the infusion solution to equilibrate to room temperature for approximately 30 minutes prior to administration. Participants will be monitored for one hour after completion of infusion. one-time dose of 1200 mg at Study Entry/Day 0 REGN10933 The REGN10933 recombinant monoclonal antibody (IgG1 isotype) is a covalent heterotetramer consisting of 2 disulphide-linked human gamma heavy chains, each covalently linked through a disulphide bond to a human kappa light chain. Based on the primary structure (excluding N-linked glycosylation), REGN10933 possesses a molecular weight of 145.23 kDa (C6454H9976N1704O2024S44), taking into account the formation of 16 disulphide bonds. There is a single N-linked glycosylation site (Asn300) on each heavy chain, located within the constant region in the Fc domain of the molecule. The complementarity-determining regions (CDRs) within the heavy chain and light chain variable domains of REGN10933 combine to form the binding sites for its target, the receptor binding domain of SARS-CoV-2 S protein. REGN10933 FDS consists of 120 mg/mL purified protein in an aqueous buffered solution, containing 10 mM L-histidine, pH 6.0, 8% (w/v) sucrose and 0.1% (w/v) polysorbate 80. REGN10933 DP is supplied as liquid solutions for IV and SC administrations. The DPs are preservative-free and nonpyrogenic. Chemical formula from primary structure: C6454H9976N1704O2024S44 REGN10987 The REGN10987 recombinant monoclonal antibody (IgG1 isotype) is a covalent heterotetramer consisting of 2 disulphide-linked human gamma heavy chains, each covalently linked through a disulphide bond to a human lambda light chain. Based on the primary structure (excluding N-linked glycosylation), REGN10987 possesses a molecular weight of 144.14 kDa (C6396H9882N1694O2018S42), taking into account the formation of 16 disulphide bonds. There is a single N-linked glycosylation site (Asn300) on each heavy chain, located within the constant region in the Fc domain of the molecule. The complementarity-determining regions (CDRs) within the heavy chain and light chain variable domains of REGN10987 combine to form the binding sites for its target, the receptor binding domain of SARS-CoV-2 S protein. REGN10987 FDS consists of 120 mg/mL purified protein in an aqueous buffered solution, containing 10 mM L-histidine, pH 6.0, 8% (w/v) sucrose and 0.1% (w/v) polysorbate 80. REGN10987 DP is supplied as liquid solutions for IV and SC administrations. The DPs are preservative-free and nonpyrogenic. Chemical formula from primary structure: C6396H9882N1694O2018S42 Mechanism of Action: The Regeneron combination therapy, REGN-COV2, has favorable properties with potential to translate into therapeutic benefit to patients with confirmed COVID-19 and prophylactic benefit to protect against infection or disease with SARS-CoV-2. REGN-COV2 is a combination of 2 fully human IgG1 mAbs (REGN10933+REGN10987) that bind non-overlapping epitopes on the RBD of the SARS-CoV-2 S protein, an exogenous protein, and neutralize virus infectivity by blocking binding to ACE2. REGN10933 and REGN10987 are intended to be utilized as a combination treatment and should not be used individually as monotherapy. For viral targets, a combination of antibodies that bind to nonoverlapping epitopes may minimize the likelihood of loss of antiviral activity due to naturally circulating viral variants or development of escape mutants under drug pressure. Regeneron has significant experience with prior development programs for fully human mAbs against exogenous targets, including atoltivimab, odesivimab, and maftivimab (also known as REGN-EB3, Ebola); REGN3048 and REGN3051 (MERS-CoV); REGN2222 (respiratory syncytial virus, RSV); REGN5713, REGN5714, and REGN 5715 (Bet v1 birch tree allergen); and REGN1908 and REGN1909 (fel d 1 cat dander allergen). The manufacturing processes for REGN10933 and REGN10987 are identical and use growth of a suspension culture of recombinant Chinese hamster ovary (CHO) cells to express REGN10933 or REGN10987 under an inducible promoter. Upon addition of doxycycline hyclate, the recombinant product is produced and secreted into the culture medium from which it is isolated an 800 Active-Treatment of Control Group
Experimental Group SAB 185 Anti SARS CoV2 Human Immunoglobulin Intravenous Tc Bovine Derived Participants may be randomized to receive either SAB-185 (3,840 Units/kg)/ Active Comparator (casirivimab and imdevimab) or SAB-185 (10,240 Units/kg)/ Active Comparator (casirivimab and imdevimab). SAB-185/ Active Comparator (casirivimab and imdevimab) is to be administered as an intravenous infusion. Two doses of SAB-185 will be studied in this study. Each dose is considered separately, as its own agent group. Participants may be randomized to receive either SAB-185 (3,840 Units/kg)/ Active Comparator (casirivimab and imdevimab) or SAB-185 (10,240 Units/kg)/ Active Comparator (casirivimab and imdevimab). SAB-185, 3,840 Units/kg Investigational Agent: SAB-185, 3,840 Units/kg, to be administered intravenously (IV) for one dose at study Entry/Day 0. OR Active Comparator (casirivimab and imdevimab), for Phase III participants only. SAB-185, 10,240 Units/kg Investigational Agent: SAB-185, 10,240 Units/kg, to be administered IV for one dose at study Entry/Day 0. OR Active Comparator (casirivimab and imdevimab), for Phase III participants only. Composition: SAB-185 is a clear, colourless sterile liquid for intravenous use formulated in 10 mM glutamic acid monosodium salt, 262 mM D-sorbitol, 0.05 mg/mL Tween 80, pH 5.5 and is stored at 2-8ºC Two doses of SAB-185 will be studied in this study. SAB-185 is a transchromosomic (Tc) bovine-derived human polyclonal antibody preparation consisting of purified human IgG molecules targeted against SARS-CoV-2 spike glycoprotein. The product is in development for use as a therapeutic agent for the treatment of COVID-19 disease caused by SARS-CoV-2. Each IgG molecule consists of two heavy chains and two light chains linked with disulphide bonds. The entire IgG molecule has a molecular weight of approximately 150 kilodaltons as evidenced by size-exclusion high performance liquid chromatography (SEC HPLC) analysis. Each heavy chain has a molecular weight of approximately 50 kilodaltons, and each light chain has a molecular weight of approximately 25 kilodaltons as measured by sodium dodecyl sulphate polyacrylamide gel electrophoresis (SDS PAGE) under reducing conditions. The drug product contains a high level of neutralizing antibodies against SARS-CoV-2 viruses. SAB-185 contains less than 2% of chimeric IgG, which contains human IgG heavy chain and bovine light chain. Other impurities in SAB-185 include bovine plasma proteins, such as bovine serum albumin (BSA), and bovine IgG, each of which are below a level of 100 parts per million (ppm). It is expected that the IgG antibodies in SAB-185 will have a 28-day half-life and distribution in humans similar to that of SAB-301, an anti-Middle East Respiratory Syndrome Coronavirus [MERS-CoV] Tc bovine hIgG, as previously evaluated in a Phase 1 clinical trial and typical for human IgG antibodies. Mechanism of Action: SAB-185 is a transchromosomic (Tc) bovine-derived human polyclonal antibody preparation consisting of purified human immunoglobulin (hIgG) molecules targeted against SARS-CoV-2 spike protein. The product is in development for use as a therapeutic agent for the treatment of Coronavirus disease 2019 (COVID-19) caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Transchromosomic (Tc) bovines may be useful in the production of fully-human polyclonal IgG antibodies to fight SARS-CoV-2 infection. The genome of Tc bovines contains a human artificial chromosome (HAC), which comprises the entire human Ig gene repertoire (human Ig heavy chain [IgH] and human kappa light chain) that reside on two different human chromosomes (i.e., the IgH locus from human chromosome 14 and the immunoglobulin kappa locus from human chromosome 2). This system in the Tc bovine uses the genetic information in the HAC provided by the immunoglobulin gene repertoires to generate diverse fully human polyclonal antibodies (pAbs). The collected plasma with Tc pAbs are passed through an affinity chromatography column, first using an anti-human IgG kappa affinity column, which captures Tc pAbs and removes residual non-hIgG and bovine plasma proteins. Through this process, SAB has generated a number of useful human pAbs that can be used as therapy for infectious agents, like SARS-CoV-2. Antibody products developed through this method have demonstrated in vivo efficacy against a range of viral infections, including, Middle Eastern Respiratory Syndrome virus (MERS-CoV), Ebola, Zika, and influenza in a variety of animal models including rodents, ferrets, and non-human primates. For SARS-CoV-2, SAB has developed SAB-185, which will use an antigen production system that is non-mammalian and non-egg based that has been shown to be safe and used in previous clinical trials of SAB-301 and SAB-136. Enzyme linked immunosorbent assay indicates that SAB-185 neutralizes not only the RBD but also the full-length spike protein. Specifically, SAB-185 is a human polyclonal antibody preparation consisting of purified human immunoglobulin (hIgG) molecules targeted against SARS-CoV-2 spike protein. This full human pAbs (hIgG/hIgκ) was produced in Tc bovines after vaccination with suitable viral antigens. This vaccination schedule was conducted with a pDNA vaccine that expressed wild-type SARS-CoV-2 spike protein, followed by additional immunizati 800
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
General Eligibility Criteria 1.1.1 Inclusion Criteria 1.1.1.1 Ability and willingness of participant (or legally authorized representative) to provide informed consent prior to initiation of any study procedures. 1.1.1.2 Individuals ≥18 years of age. 1.1.1.3 Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g., oropharyngeal, NP, or nasal swab, or saliva) collected ≤240 hours prior to study entry and conducted at any US clinic or laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent or any non-US DAIDS-approved laboratory. 1.1.1.4 Participants must be expected to begin study treatment no more than 7 days from self-reported onset of COVID-19 related symptoms or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list: • subjective fever or feeling feverish • cough • shortness of breath or difficulty breathing at rest or with activity • sore throat • body pain or muscle pain/aches • fatigue • headache • chills • nasal obstruction or congestion • nasal discharge • loss of taste or smell • nausea or vomiting • diarrhea • documented temperature >38°C 1.1.1.5 One or more of the following signs/symptoms present within 24 hours prior to study entry: • subjective fever or feeling feverish • cough • shortness of breath or difficulty breathing at rest or with activity • sore throat • body pain or muscle pain/aches • fatigue • headache • chills • nasal obstruction or congestion • nasal discharge • nausea or vomiting • diarrhea • documented temperature >38°C 1.1.1.6 Oxygenation saturation of ≥92% obtained at rest by study staff within 24 hours prior to study entry. For a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition their oxygen saturati 1.1.1 Exclusion Criteria 1.1.1.1 History of or current hospitalization for COVID-19. 1.1.1.2 For the current SARS-CoV-2 infection, any positive SARS-CoV-2 nucleic acid or antigen tests from any respiratory tract specimen (e.g., oropharyngeal, NP, or nasal swab, or saliva) collected ˃240 hours prior to study entry. 1.1.1.3 Current need for hospitalization or immediate medical attention in the clinical opinion of the site investigator. 1.1.1.4 Use of any prohibited medication listed in section 5.4.1 and/or use of systemic or inhaled steroids for the purpose of COVID-19 treatment (new or increased dose from chronic baseline) within 30 days prior to study entry. 1.1.1.5 Receipt of convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 treatment or prophylaxis at any time prior to study entry. 1.1.1.6 Receipt of other available investigational treatments for SARS-CoV-2 at any time prior to study entry. This does not include drugs approved for other uses and taken for those uses. NOTE: This does not include COVID-19 vaccines. 1.1.1.7 Known allergy/sensitivity or any hypersensitivity to components of the investigational agent or placebo. See relevant appendix. 1.1.1.8 Any co-morbidity requiring surgery within 7 days prior to study entry, or that is considered life threatening in the opinion of the site investigator within 30 days prior to study entry. 1.1.1.9 Additional exclusion criteria as appropriate for the investigational agent (see relevant appendix/appendices). Adult: 19 Year-44 Year 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/10/2021 THE UNIVERSITY OF ZAMBIA BIOMEDICAL RESEARCH ETHICS COMMITTEE UNZABREC
Ethics Committee Address
Street address City Postal code Country
Ridgeway Campus, P.O. Box 50110 Lusaka 50110 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1 Phase II: Primary Outcome Measures 1.1 Clinical (Symptom Duration): Duration of targeted COVID-19 associated symptoms from start of investigational agent (day 0) based on self-assessment. Duration defined as the number of days from start of investigational treatment to the first of two consecutive days when any symptoms scored as moderate or severe at study entry (pre-treatment) are scored as mild or absent, AND any symptoms scored as mild or absent at study entry (pre-treatment) are scored as absent. The targeted symptoms are feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain or aches, fatigue (low energy), headache, chills, nasal obstruction or congestion (stuffy nose), nasal discharge (runny nose), nausea, vomiting, and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) and severe (3). 1.2 Virologic: At each of days 3, 7, and 14 quantification (<LLoQ versus ≥LLoQ) of SARS-CoV-2 RNA from staff-collected NP swabs. 1.3 Safety: New Grade 3 or higher AE through 28 days. 2.2 Phase III: Primary Outcome Measures - applicable to Zambia Sites 2.1 Efficacy: Death due to any cause or hospitalization due to any cause during the 28-day period from and including the day of the first dose of investigational agent or placebo. Hospitalization is defined as ≥24 hours of acute care, in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19 during the COVID-19 pandemic. 2.2 Safety: New Grade 3 or higher AE through 28 days. 28
Secondary Outcome Secondary Outcome Measures The clinical primary outcome measure in phase II (symptom duration) will also be assessed in phase III as a secondary outcome measure. The virologic primary outcome measure in phase II (quantification (<LLoQ versus ≥LLoQ) of SARS-CoV-2 RNA from staff-collected NP swabs) will also be assessed in phase III as a secondary outcome measure, except only at Day 3. The primary outcome measure in phase III (death due to any cause or hospitalization due to any cause through 28 days) will also be assessed in phase II as a secondary outcome measure. The following secondary outcome measures will also be assessed: 1.1 Phase II and III: Level of SARS-CoV-2 RNA from staff-collected NP l swabs through day 14 in phase II and at day 3 in phase III. 1.2 Phases II and III: Duration of targeted COVID-19 associated symptoms from start of investigational agent (day 0) based on self-assessment. Duration defined as the number of days from start of investigational treatment to the first of four consecutive days when all symptoms are scored as absent. The targeted symptoms are feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain or aches, fatigue (low energy), headache, chills, nasal obstruction or congestion (stuffy nose), nasal discharge (runny nose), nausea, vomiting, and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2), and severe (3). 1.3 Phases II and III: COVID-19 severity ranking based on symptom severity scores over time during the 28-day period from and including the day of the first dose of investigational agent or placebo, hospitalization, and death. For participants who are alive at 28 days and not previously hospitalized, the severity ranking will be based on their area under the curve AUC of the daily total symptom score associated with COVID-19 over time (through 28 days counting day 0 as the first day) where the total symptom score on a given day is defined as the sum of scores for the targeted symptoms in the participant’s study diary (each individual symptom is scored from 0 to 3). Participants who are hospitalized or who die during follow-up through 28 days will be ranked as worse than those alive and never hospitalized as follows (in worsening rank order): alive and not hospitalized at 28 days; hospitalized but alive at 28 days; and died at or before 28 days. 1.4 Phases II and III: Progression through day 28 of one or more COVID-19-associated symptoms to a worse status than recorded in the study diary at study entry, prior to start of investigational agent or placebo. 1.5 Phases II and III: Time to self-reported return to usual health, defined as the number of days from start of investigational treatment until the first of two consecutive days that a participant reported return to usual (pre-COVID-19) health as recorded in a participant’s study diary through Day 28. 1.6 Phases II and III: Death due to any causeor hospitalization due to any cause during the 24-week period from and including the day of the first dose of investigational agent, and during the 72-week period from and including the day of the first dose of investigational agent. 1.7 Phase II only: Oxygen saturation (i.e., pulse oximeter measures) as a quantitative measure and categorized as <96 versus ≥96% through day 28. 1.8 Phase II only: Area under the curve and above the assay lower limit of quantification of quantitative SARS-CoV-2 RNA over time from site-collected NP swabs at days 0, 3, 7 and 14. 1.9 Phases II and III: Phases II and III: New Grade 2 or higher AE through 28 days, and through week 24,. 1.10 Phases II and III: New Grade 3 or higher AE through week 24. 1.11 Phase II only: Pharmacokinetic measures will be defined in the agent-specific appendices. 1.12 Phase II and III: Time to self-reported return to usual health, defined as the number of days from start of investigational tre 28
Secondary Outcome Other Outcome Measures 1.1 Phases II and III: Worst clinical status assessed using ordinal scale among participants who become hospitalized. Ordinal scale defined as: death hospitalized, on invasive mechanical ventilation or ECMO; hospitalized, on non-invasive ventilation or high flow oxygen devices; hospitalized, requiring supplemental oxygen; hospitalized, not requiring supplemental oxygen (COVID-19 related or otherwise) 1.2 Phases II and III: Duration of hospital stay among participants who become hospitalized. 1.3 Phases II and III: ICU admission (yes versus no) among participants who become hospitalized. 1.4 Phases II and III: Duration of ICU admission among participants who are admitted to the ICU. 1.5 Phases II and III: New SARS-CoV-2 positivity among household contacts through to 28 days and through to 24 weeks from start of investigational agent or placebo. 1.6 Phases II and III: Hematology and chemistry, coagulation, and inflammatory markers through 28 days from start of investigational agent. 1.7 Phases II and III: Plasma markers of inflammation and antibody responses to SARS-CoV-2 infections, measured in blood in all phase II participants and in a subset of phase III participants per relevant appendix. 1.8 Phase II and III: Viral resistance (to be defined at the time of laboratory analysis). 1.9 Phase II only: Immune cell phenotypes and T and B cell responses to SARS-CoV-2 measured in PBMCs (to be defined at the time of laboratory analysis). 1.10 Phase II and III: Persistent clinical symptoms and sequelae through end of study follow-up. 1.11 Phase II and III: Psychological health, functional health, and health-related quality of life measures through end of study follow-up. 24 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Center for Family Health Research in Zambia Lusaka Dr. William Kilembe B22/F737 Mwembelelo Rd, Emmasdale Lusaka Zambia
Center for Family Health Research in Zambia Ndola Dr. William Kilembe 24 Lupili Road, Northrise Ndola Zambia
Centre for Infectious Disease Research in Zambia Professor Roma Chilengi Plot 34620 Corner of Lukasu and Danny Pule Roads, Mass Media Lusaka 10101 Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute of Allergy and Infectious Diseases NIAID 5601 Fishers Lane Rockville, Maryland 20852 Room 9B31B 1 240 292 Rockville 4905 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Institute of Allergy and Infectious Diseases 5601 Fishers Lane Rockville, Maryland 20852 Room 9B31B 1240292 Rockville 4905 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Roma Chilengi Roma.Chilengi@cidrz.org 260211242257 Centre for Infectious Disease Research in Zambia CIDRR Plot 34620 Corner of Lukasu and Danny Pule Roads, Mass Media, P.O. Box 34681
City Postal code Country Position/Affiliation
Lusaka Zambia Investigator
Role Name Email Phone Street address
Public Enquiries William Kilembe wkilembe@rzhrg-mail.org +26096862787 Center for Family Health Research in Zambia-Lusaka B22 F737 Mwembelelo Rd, Emmasdale, Postnet 412, P Bag E891
City Postal code Country Position/Affiliation
Lusaka Zambia Investigator
Role Name Email Phone Street address
Scientific Enquiries MUBIANA INAMBAO minambao@rzhrg-mail.org +260966780601 Center for Family Health Research in Zambia Ndola, 24 Lupili Rd, Northrise PO 240262
City Postal code Country Position/Affiliation
Northrise Zambia Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Electronic case report form (eCRF) screens will be made available to sites for data entry. Participants will not be identified by name on any data submitted to the DMC. Participants will be identified by the subject number provided by the Clinical Data Management System (CDMS) upon enrollment. All laboratory specimens, evaluation forms, reports, and other records that leave the site will be identified by coded number only to maintain participant confidentiality. All records will be kept locked. All computer entry and networking programs will be done with coded numbers only. Clinical information will not be released without written permission of the participant, except as necessary for monitoring by the ACTG, IRB/EC, FDA, NIAID, OHRP, other local, US, and international regulatory authorities/entities as part of their duties, or the industry supporter(s) or designee. Publication of the results of this trial will be governed by ACTG policies. Any presentation, abstract, or manuscript will be made available for review by the industry supporter(s) prior to submission. Study Protocol Not specified. Publication of the results of this trial will be governed by ACTG policies. Any presentation, abstract, or manuscript will be made available for review by the industry supporter(s) prior to submission.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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