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.: PACTR202009769021840 Date of Approval: 02/09/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Whole-lung low dose radiation therapy (LDRT) in the treatment of severe COVID-19 pneumonia
Official scientific title A pilot phase Ib/II study of whole-lung low dose radiation therapy (LDRT) in the treatment of severe Covid 19 pneumonia patients on (or requiring) mechanical ventilatory support. COVID-19
Brief summary describing the background and objectives of the trial Background. Low-dose radiation therapy (LDRT) improves clinical, radiographic, and immune outcomes in hospitalized patients with covid-19 pneumonia and severe acute respiratory syndrome. This study investigates LDRT as a selectively localized anti-inflammatory treatment to induce focal suppression of pulmonary immuno-toxicity within viral pneumonia infiltrates in hospitalized patients with COVID19. The study will administer of low dose whole lung radiotherapy (LDRT) for the treatment of severe COVID 19 pneumonia in patients on or requiring mechanical ventilation Primary Objective: 1. To assess the feasibility and safety of administering LDRT to patients with severe Covid 19 pneumonia 2. To assess the toxicity of a single dose of LDRT administered to patients with severe Covid 19 pneumonia Secondary Objective: 1. Improvement in oxygen requirement at 3 days following LDRT 2. Ability to come off mechanical (or avoid mechanical) ventilation within 7 days following LDRT 3. Discharge by 14d and 28d following LDRT 4. Death by 14d and 28d following LDRT
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied COVID 19 PNEUMONIA
Purpose of the trial Treatment: Other
Anticipated trial start date 15/09/2020
Actual trial start date
Anticipated date of last follow up 15/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
IERC 111 Aga Khan university, Ethical Review Committee
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Low dose radiotherapy Single Low Dose Radiation therapy of 100cGy once Eligible patients will receive a single dose of LDRT of 100cGy which has been found to be safe and efficient is comparable settings. Patients will be followed for toxicity for the duration of their hospital stay with specific study related endpoints being determined at 24h, 3d, 7d, 14d, and 28d. 20
Control Group NA N/A N/A N.A 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a. Be age 18 or over b. Have had a positive rtPCR test confirming the diagnosis of COVID-19 from nasopharyngeal swab, Sputum or lower respiratory tract sample c. Have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrolment) d. Documented pO2 < 94% while on ambient air on admission, and requires supplemental oxygen to maintain pO2 ≥ 94%. 1. Cohort 1: currently not on mechanical ventilation but would need mechanical ventilation if condition worsens (pre-Vent) 2. Cohort 2: currently on mechanical ventilation for ≤ 5 days (on-Vent) e. Have visible consolidations/ground glass opacities on chest x-ray or computed tomography consisted with Covid 19 pneumonia. f. The patient, according to the treating physician, has received medical treatment considered best practice as per the institution’s guidelines, and does not show improvement g. Willingness and ability of the subject to comply with scheduled visits, protocol-specified laboratory tests, other study procedures, and study restrictions. h. Evidence of a signed informed consent/assent indicating that the subject is aware of the infectious nature of the disease and has been informed of the procedures to be followed, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation. a. Pre-existing lung comorbidity such as severe COPD, severe uncontrolled asthma or heart failure or concomitant active systemic infection. b. Pre-existing dependency on supplemental oxygen prior to diagnosis of Covid 19 pneumonia c. Patients on mechanical ventilation requiring 100% FIO2 and > 8mm PEEP to maintain pO2 > 94% will not be eligible d. Unwilling or unable to following protocol procedures e. Pregnant and/or planned to be pregnant within in next 6 months f. Hemodynamic and Ventilatory instability precluding transfer to Radiation Oncology department 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 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
No 06/08/2020 Agakhan University Hospital Nairobi
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue, off Limuru Road, Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1) Safety/Feasibility – % patients able to complete LDRT without treatment related SAE at 24h following LDRT 2) Toxicity – % patients without worsening of vital signs to assess clinical and respiratory status at 24h following LDRT (CTCAE acute toxicity criteria) within 24 hours
Secondary Outcome 1) Efficacy - % patient able to be weaned off pre-LDRT ventilatory or oxygen support at 3d post LDRR 2) Efficacy - % patients able to come off (or avoid) mechanical ventilation within 7 days following LDRT 3) Efficacy - % patients discharged or expired at 14d/28d post LDR day 3 day 7 day 14 day 28
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AgaKhan University Hospital Nairobi 3rd Parklands Avenue, off Limuru Road, Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Aga Khan University Hospital Nairobi 3rd Parklands Avenue, off Limuru Road, Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Agakhan University Hospital Nairobi 3rd Parklands Avenue, off Limuru Road, Nairobi 00100 Kenya Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MANSOOR SALEH mansoor.saleh@aku.edu +254780428334 3rd Parklands Avenue, off Limuru Road,
City Postal code Country Position/Affiliation
NAIROBI 00100 Kenya Aga Khan university Nairobi
Role Name Email Phone Street address
Public Enquiries WANGARI SIIKA AKUKenya.ResearchOffice@aku.edu +254203662148 3rd Parklands Avenue, off Limuru Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya AgaKhan University Nairobi
Role Name Email Phone Street address
Scientific Enquiries FARROK KARSAN farrok.karsan@aku.edu +254203662644 3rd Parklands Avenue, off Limuru Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Aga Khan university Nairobi
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the result of the study after deidentification Study Protocol Beginning 9 months after sharing and ending 36 months after publication of study Outside investigators upon scientific review of the merits of their proposed research plan
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information