Trial no.:	PACTR202004761408382	Date of Approval:	15/04/2020
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Efficacy and safety of IHP Detox Tea (a special blend of Andrographis paniculata, Garcinia kola and Psidium guajava) for treatment of Corona virus disease 2019 (COVID-19): a pilot randomized trial

Official scientific title

Efficacy and safety of IHP Detox Tea (a special blend of Andrographis paniculata, Garcinia kola and Psidium guajava) for treatment of Corona virus disease 2019 (COVID-19): a pilot randomized trial

Brief summary describing the background and objectives of the trial

The escalating outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is stretching health systems globally beyond comprehension. The ensuing corona virus disease 2019 (COVID-19) has become a challenging source of morbidity and mortality across the globe. Within four months of the COVID-19 virus outbreak well over 1.6 million people have been infected with a global mortality rate of over 5.9% (Global summary, 2020, as at April 11, 2020). Although there is a massive global rush to optimize prophylactic or therapeutic strategies, indigenous drugs have again taken a back stage of time. Intercedd Health product (IHP) Detox Tea (a validated marketed nutraceutical) could serve as an effective standalone or an adjuvant in the current treatment of COVID-19. The reason is that published reports have suggested a seemingly high efficacy of the major components of the IHP Detox tea in alleviating the symptoms of acute respiratory tract infections in both adults and children. However little is known about the role of IHP Detox tea when used as a standalone or co-administered with the currently being evaluated therapy for treatment of COVID-19. To our knowledge, there is no prior randomized trial on the effectiveness of IHP Detox Tea when co-administered with currently used therapy for treatment or prophylaxis of COVID-19. Objectives: To determine the efficacy and safety of IHP Detox Tea, when used as adjuvants to the conventional therapy for treatment of novel COVID-19.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

IHP Detox tea trial

Disease(s) or condition(s) being studied

Infections and Infestations

Sub-Disease(s) or condition(s) being studied

COVID-19

Purpose of the trial

Treatment: Drugs

Anticipated trial start date

01/05/2020

Actual trial start date

Anticipated date of last follow up

31/08/2020

Actual Last follow-up date

Anticipated target sample size (number of participants)

72

Actual target sample size (number of participants)

Recruitment status

Completed

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	Simple randomization using a randomization table created by a computer software program	Sealed opaque envelopes	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	IHP Detox tea	One teabag of IHP Detox Tea to be soaked in 100mL of warm water 12 hourly in combination with conventional therapy	4 weeks	Standard doses of IHP Detox Tea (one teabag to be soaked in 100mls of warm water 12 hourly) will be administered in conjunction with conventional therapy for COVID-19 12-hourly for 4 weeks.	36
Control Group	Conventional therapy only	Conventional therapy for COVID-19 12-hourly	4 weeks	Conventional therapy for COVID-19 12-hourly for 4 weeks	36	Historical

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Adult patients with confirmed clinical and laboratory diagnosis of COVID-19. Patients with normal liver and renal function markers.	Pregnant, lactating and breastfeeding women. Patients with diabetes or with serious ailments of heart, liver, kidney or brain. Chronic medical disorders including HIV/AIDS, Cancers, etc. Subjects who have any allergy or were allergic to any of the medication to be used.	Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s)	18 Year(s)	64 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

09/04/2020

National Health Research Ethics Committee

Ethics Committee Address
Street address	City	Postal code	Country
Garki, Abuja P.M.B. 083, Garki-Abuja	Abuja	434001	Nigeria

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	The mean time to negative test to COVID-19.	first negative test or discharge
Primary Outcome	Presence of immune determinants.	within 10 days of recruitment
Secondary Outcome	Proportion of patients with persisting respiratory symptoms (cough, expectoration, nasal discharge, headache, fever, sore throat, earache, malaise/fatigue and sleep disturbance)	at two and four weeks of therapy
Secondary Outcome	Incidence of any adverse events (such as diarrhea, nausea, vomiting and colitis)	within 10 days of commencement of therapy
Secondary Outcome	Mean levels of renal function parameters (serum electrolyte, urea and creatinine).	at two weeks after initial therapy
Secondary Outcome	Mean levels of liver function parameters (AST, ALT and ALP) and lipid profiles.	at two weeks after initial therapy
Secondary Outcome	Proportion of patients discharged from hospital or deaths	at 2 weeks and 4 weeks of therapy
Secondary Outcome	Effects (if any) on CD4+ and CD8+ counts of both Study Arms	at two weeks and 4 weeks of therapy

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
LUTH Lagos Isolation Center	Ishaga Rd, Idi-Araba, Lagos	Lagos		Nigeria
University of Abuja Teaching Hospital Isolation Center	Gwagwalada-Zuba, Gwagwalada	Abuja		Nigeria

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
International Centre for Ethnomedicine and Drug Development and Neimeth International Pharmaceuticals Plc.	1 JB Leton Close, Off Abdullahi Ibrahim Crescent, Off TOS Benson, Okonjo Iweala Way, Utako District Abuja, / Ikeja Industrial Estate, 1 Henry Carr St, Ikeja	ABUJA and Ikeja Lagos		Nigeria

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	International Centre for Ethnomedicine and Drug Development and Neimeth International Pharmaceuticals Plc.	Ikeja Industrial Estate, 1 Henry Carr St,	Ikeja		Nigeria	Commercial Sector/Industry

COLLABORATORS
Name	Street address	City	Postal code	Country
Joseph Ikechebelu	Nnewi Onitsha Road	Nnewi		Nigeria
George Eleje	Nnewi Onitsha Road	Nnewi		Nigeria
Jude Duru	Lagos University Teaching Hospital is a tertiary hospital in Idi-Araba, Surulere, Lagos State	Surulere		Nigeria
George Chukwuma	Okofia Campus	Awka		Nigeria
Festus Okoye	Along Enugu-Onitsha Expressway, Ifite Road, 420110, Awka	Awka		Nigeria
Kenneth Ngwoke	Nnamdi Azikiwe University, Enugu-Onitsha Expressway, Ifite Road, 420110, Awka	Awka		Nigeria
Godwin Nchinda	CIRCB BP 3077, Messa Yaounde,	Yaounde		Cameroon
Henrietta Ogbunugafor	Nnamdi Azikiwe University, Enugu-Onitsha Expressway, Ifite Road, 420110, Awka	Awka		Nigeria
Edamisan Olusoji TEMIYE	Department of Paediatrics, College of Medicine, Lagos University Teaching Hospital	Lagos		Nigeria
Suleiman Alani AKANMU	Department of Haematology, College of Medicine, Lagos University Teaching Hospital	Lagos		Nigeria
David Adewale OKE	Department of Medicine, College of Medicine, Lagos University Teaching Hospital	Lagos		Nigeria
Sunday .A. OMILABU	Department of Medical Microbiology and Parasitology College of Medicine, Lagos University Teaching Hospital	Lagos		Nigeria
Iorhen Ephraim AKASE	Department of Medicine, College of Medicine, Lagos University Teaching Hospital	Lagos		Nigeria

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Charles Esimone	co.esimone@unizik.edu.ng	+2348062835781	Nnamdi Azikiwe University, Enugu-Onitsha Expressway, Ifite Road, 420110, Awka
City	Postal code	Country	Position/Affiliation
Awka		Nigeria	Professor
Role	Name	Email	Phone	Street address
Scientific Enquiries	George Eleje	georgel21@yahoo.com	+234806811744	49 Nnewi Onitsha Road, NAUTH Nnewi
City	Postal code	Country	Position/Affiliation
Nnewi		Nigeria	Senior Lecturer and Consultant
Role	Name	Email	Phone	Street address
Public Enquiries	Jude Duru	jduruonweni2203@hotmail.com	+2348037212638	Ishaga Rd, Idi-Araba
City	Postal code	Country	Position/Affiliation
Idi Araba		Nigeria	Consultant

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	APPENDIX 1: PROFORMA: Efficacy and safety of IHP Detox Tea (a special blend of Andrographis paniculata, Garcinia kola and Psidium guajava) for treatment of Corona virus disease 2019 (COVID-19): a pilot placebo-controlled randomized trial NAME OF DOCTOR................................................CODE NUMBER oor OF PATIENT……………………… (1). COMPUTER NUMBER OF PATIENT..........................(2) Educational level………………………… (3). DATE OF RECRUITMENT......................(4) TIME..................(5) AGE....................... (6.) Marital status: Married [ ] [single [ ] Divorced [ ](7.) LMP………..(8)Date of diagnosis.............. (9). Travel history Yes [ ] No [ ].................(10). Body weight-.............(11). Height: (cm)...................................................... TICK [X] OR WRITE WHICHEVER IS APPROPRIATE. (12) Prior RETROVIRAL DISEASE STATUS a.) Negative [ ] (b) Positive [ ] (14). HIGHEST EDU LEVEL.................................(15.) OCCUPATION (Specify).............................. (16). PREVIOUS Chronic infection? (a.) YES—-(b.) NO----- (16B) Known Hypertensive Yes [ ], NO [ ] (18). FINDINGS AT CLINICAL EXAMINATION AT RECRUITMENT AND AT DISCHARGE ? TICK [√] below: VARIABLE AT RECRUITEMNT PRESENCE ABSENCE VAS SCORE VARIABLE At 4 weeks/discharge PRESENCE ABSENCE VAS SCORE Expectoration Expectoration Nasal discharge Nasal discharge Fever Fever Sore throat Sore throat Headache Headache Cough Cause Earache Earache Malaise/fatigue Malaise/fatigue Sleep disturbance Sleep disturbance Diarrhea Diarrhea 19. SOME LABORATORY PARAMETERS LABORATORY VARIABLE VALUES AT BASELINE VALUES IN DISCHARGE NORMAL RANGES HIV HBV HCV Na K Bicarbonate Chloride AST ALP ALT Bilirubin PCV or HCT Hb Wbc Platelets ANTIBODY TESTING	Clinical Study Report,Informed Consent Form	It will be available from July 2020 to October 2020	Open access.
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
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Trial description	14/04/2020	edit	The escalating outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is stretching health systems globally beyond comprehension. The ensuing corona virus disease 2019 (COVID-19) has become a challenging source of morbidity and mortality across the globe. Within four months of the COVID-19 virus outbreak well over 1.6 million people have been infected with a global mortality rate of over 5.9% (Global summary, 2020, as at April 11, 2020). Although there is a massive global rush to optimize prophylactic or therapeutic strategies, indigenous drugs have again taken a back stage of time. Intercedd Health product (IHP) Detox Tea (a validated marketed nutraceutical) could serve as an effective standalone or an adjuvant in the current treatment of COVID-19. The reason is that published reports have suggested a seemingly high efficacy of the major components of the IHP Detox tea in alleviating the symptoms of acute respiratory tract infections in both adults and children. However little is known about the role of IHP Detox tea when used as a standalone or co-administered with the currently being evaluated therapy for treatment of COVID-19. To our knowledge, there is no prior randomized trial on the effectiveness of IHP Detox Tea when co-administered with currently used therapy for treatment or prophylaxis of COVID-19. Objectives To determine the efficacy and safety of IHP Detox Tea, when used as adjuvants to the conventional therapy for treatment of novel COVID-19.	The escalating outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is stretching health systems globally beyond comprehension. The ensuing corona virus disease 2019 (COVID-19) has become a challenging source of morbidity and mortality across the globe. Within four months of the COVID-19 virus outbreak well over 1.6 million people have been infected with a global mortality rate of over 5.9% (Global summary, 2020, as at April 11, 2020). Although there is a massive global rush to optimize prophylactic or therapeutic strategies, indigenous drugs have again taken a back stage of time. Intercedd Health product (IHP) Detox Tea (a validated marketed nutraceutical) could serve as an effective standalone or an adjuvant in the current treatment of COVID-19. The reason is that published reports have suggested a seemingly high efficacy of the major components of the IHP Detox tea in alleviating the symptoms of acute respiratory tract infections in both adults and children. However little is known about the role of IHP Detox tea when used as a standalone or co-administered with the currently being evaluated therapy for treatment of COVID-19. To our knowledge, there is no prior randomized trial on the effectiveness of IHP Detox Tea when co-administered with currently used therapy for treatment or prophylaxis of COVID-19. Objectives: To determine the efficacy and safety of IHP Detox Tea, when used as adjuvants to the conventional therapy for treatment of novel COVID-19.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Funding Source	FundingSources List	14/04/2020	The funding source was inadvertently missed during the initial registration of the trial at pactr.org. We do apologize for the initial omission.		Neimeth International Pharmaceuticals Plc., Ikeja Industrial Estate, 1 Henry Carr St, Ikeja, Ikeja, , Nigeria, Commercial Sector / Industry,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Funding Source	FundingSources List	14/04/2020	We inadvertently missed the funding source at the time of initial trial registration. We apologize.	Neimeth International Pharmaceuticals Plc., Ikeja Industrial Estate, 1 Henry Carr St, Ikeja, Ikeja, , Nigeria, Commercial Sector / Industry,	Neimeth International Pharmaceuticals Plc., Ikeja Industrial Estate, 1 Henry Carr St, Ikeja, Ikeja Lagos, , Nigeria, Commercial Sector / Industry,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Public title	09/06/2020	Placebo will not be used again in this pilot study because the trialists and investigators felt placebo will be used in larger trials, and not in the pilot study stage.	Efficacy and safety of IHP Detox Tea (a special blend of Andrographis paniculata, Garcinia kola and Psidium guajava) for treatment of Corona virus disease 2019 (COVID-19): a pilot placebo-controlled randomized trial	Efficacy and safety of IHP Detox Tea (a special blend of Andrographis paniculata, Garcinia kola and Psidium guajava) for treatment of Corona virus disease 2019 (COVID-19): a pilot randomized trial
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Official scientific title	09/06/2020	Placebo will not be used again in this pilot study because the trialists and investigators felt placebo will be used in larger trials, and not in the pilot study stage.	Efficacy and safety of IHP Detox Tea (a special blend of Andrographis paniculata, Garcinia kola and Psidium guajava) for treatment of Corona virus disease 2019 (COVID-19): a pilot placebo-controlled randomized trial	Efficacy and safety of IHP Detox Tea (a special blend of Andrographis paniculata, Garcinia kola and Psidium guajava) for treatment of Corona virus disease 2019 (COVID-19): a pilot randomized trial
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Study Design	Masking type	09/06/2020	Placebo agents for IHP Detox tea has been removed from the protocol for the pilot study.	Masking/blinding used	Open-label(Masking Not Used)
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Study Design	Masking / blinding	09/06/2020	None of the caregivers, outcome assessors or participants will now be blinded because the placebo agent for IHP Detox tea has been removed from the protocol.	Participants
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	09/06/2020	Placebo will not be used again in this pilot study because the trialists and investigators felt placebo will be used in larger trials, not in the present pilot study.	Control Group, Placebo, Placebo (one teabag to be soaked in 100mls of warm water 12-hourly) in conjunction with conventional therapy for COVID-19 12-hourly , 4 weeks, Placebo (one teabag to be soaked in 100mls of warm water 12-hourly) in conjunction with conventional therapy for COVID-19 12-hourly for 4 weeks, 36, Placebo	Control Group, Conventional therapy only, Conventional therapy for COVID-19 12-hourly , 4 weeks, Placebo (one teabag to be soaked in 100mls of warm water 12-hourly) in conjunction with conventional therapy for COVID-19 12-hourly for 4 weeks, 36, Placebo
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	09/06/2020	Placebo will not be used again in this pilot study because the trialists and investigators felt placebo will be used in larger trials, not pilot study.	Control Group, Conventional therapy only, Conventional therapy for COVID-19 12-hourly , 4 weeks, Placebo (one teabag to be soaked in 100mls of warm water 12-hourly) in conjunction with conventional therapy for COVID-19 12-hourly for 4 weeks, 36, Placebo	Control Group, Conventional therapy only, Conventional therapy for COVID-19 12-hourly , 4 weeks, Conventional therapy for COVID-19 12-hourly for 4 weeks, 36, Historical
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Funding Source	FundingSources List	09/06/2020	International center for Ethnomedicine and drug development will now be the major funder for now.	Neimeth International Pharmaceuticals Plc., Ikeja Industrial Estate, 1 Henry Carr St, Ikeja, Ikeja Lagos, , Nigeria, Commercial Sector / Industry,	International Centre for Ethnomedicine and Drug Development and Neimeth International Pharmaceuticals Plc., 1 JB Leton Close, Off Abdullahi Ibrahim Crescent, Off TOS Benson, Okonjo Iweala Way, Utako District Abuja, / Ikeja Industrial Estate, 1 Henry Carr St, Ikeja, ABUJA and Ikeja Lagos, , Nigeria, Commercial Sector / Industry,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Funding Source	FundingSources List	09/06/2020	International center for Ethnomedicine and drug development will now be the major funder for now for efficiency.	Neimeth International Pharmaceuticals Plc., Ikeja Industrial Estate, 1 Henry Carr St, Ikeja, Ikeja Lagos, , Nigeria, Commercial Sector / Industry,	International Centre for Ethnomedicine and Drug Development and Neimeth International Pharmaceuticals Plc., 1 JB Leton Close, Off Abdullahi Ibrahim Crescent, Off TOS Benson, Okonjo Iweala Way, Utako District Abuja, / Ikeja Industrial Estate, 1 Henry Carr St, Ikeja, ABUJA and Ikeja Lagos, , Nigeria, Commercial Sector / Industry,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Sponsors	Sponsors List	09/06/2020	International center for Ethnomedicine and drug development will now be the major funder for now for efficiency.	Neimeth International Pharmaceuticals Plc., Ikeja Industrial Estate, 1 Henry Carr St, , Ikeja, , Nigeria, Primary Sponsor, Commercial Sector/Industry,	International Centre for Ethnomedicine and Drug Development and Neimeth International Pharmaceuticals Plc., Ikeja Industrial Estate, 1 Henry Carr St, , Ikeja, , Nigeria, Primary Sponsor, Commercial Sector/Industry,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Collaborators	Collaborators List	09/06/2020	A new trialist.		Edamisan Olusoji TEMIYE , Department of Paediatrics, College of Medicine, Lagos University Teaching Hospital , Lagos, , Nigeria
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Collaborators	Collaborators List	09/06/2020	A new trialist		Suleiman Alani AKANMU, Department of Haematology, College of Medicine, Lagos University Teaching Hospital , Lagos, , Nigeria
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Collaborators	Collaborators List	09/06/2020	A new trialist		David Adewale OKE , Department of Medicine, College of Medicine, Lagos University Teaching Hospital , Lagos, , Nigeria
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Collaborators	Collaborators List	09/06/2020	A new trialist		Sunday .A. OMILABU , Department of Medical Microbiology and Parasitology College of Medicine, Lagos University Teaching Hospital , Lagos, , Nigeria
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Collaborators	Collaborators List	09/06/2020	A new trialist		Iorhen Ephraim AKASE , Department of Medicine, College of Medicine, Lagos University Teaching Hospital, Lagos, , Nigeria
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD description	09/06/2020	PCV or HCT added because they are the same	APPENDIX 1: PROFORMA: Efficacy and safety of IHP Detox Tea (a special blend of Andrographis paniculata, Garcinia kola and Psidium guajava) for treatment of Corona virus disease 2019 (COVID-19): a pilot placebo-controlled randomized trial NAME OF DOCTOR................................................CODE NUMBER OF PATIENT……………………… (1). COMPUTER NUMBER OF PATIENT..........................(2) Educational level………………………… (3). DATE OF RECRUITMENT......................(4) TIME..................(5) AGE....................... (6.) Marital status: Married [ ] [single [ ] Divorced [ ](7.) LMP………..(8)Date of diagnosis.............. (9). Travel history Yes [ ] No [ ].................(10). Body weight-.............(11). Height: (cm)...................................................... TICK [X] OR WRITE WHICHEVER IS APPROPRIATE. (12) Prior RETROVIRAL DISEASE STATUS a.) Negative [ ] (b) Positive [ ] (14). HIGHEST EDU LEVEL.................................(15.) OCCUPATION (Specify).............................. (16). PREVIOUS Chronic infection? (a.) YES—-(b.) NO----- (16B) Known Hypertensive Yes [ ], NO [ ] (18). FINDINGS AT CLINICAL EXAMINATION AT RECRUITMENT AND AT DISCHARGE ? TICK [√] below: VARIABLE AT RECRUITEMNT PRESENCE ABSENCE VAS SCORE VARIABLE At 4 weeks/discharge PRESENCE ABSENCE VAS SCORE Expectoration Expectoration Nasal discharge Nasal discharge Fever Fever Sore throat Sore throat Headache Headache Cough Cause Earache Earache Malaise/fatigue Malaise/fatigue Sleep disturbance Sleep disturbance Diarrhea Diarrhea 19. SOME LABORATORY PARAMETERS LABORATORY VARIABLE VALUES AT BASELINE VALUES IN DISCHARGE NORMAL RANGES HIV HBV HCV Na K Bicarbonate Chloride AST ALP ALT Bilirubin PCV Hb Wbc Platelets ANTIBODY TESTING	APPENDIX 1: PROFORMA: Efficacy and safety of IHP Detox Tea (a special blend of Andrographis paniculata, Garcinia kola and Psidium guajava) for treatment of Corona virus disease 2019 (COVID-19): a pilot placebo-controlled randomized trial NAME OF DOCTOR................................................CODE NUMBER oor OF PATIENT……………………… (1). COMPUTER NUMBER OF PATIENT..........................(2) Educational level………………………… (3). DATE OF RECRUITMENT......................(4) TIME..................(5) AGE....................... (6.) Marital status: Married [ ] [single [ ] Divorced [ ](7.) LMP………..(8)Date of diagnosis.............. (9). Travel history Yes [ ] No [ ].................(10). Body weight-.............(11). Height: (cm)...................................................... TICK [X] OR WRITE WHICHEVER IS APPROPRIATE. (12) Prior RETROVIRAL DISEASE STATUS a.) Negative [ ] (b) Positive [ ] (14). HIGHEST EDU LEVEL.................................(15.) OCCUPATION (Specify).............................. (16). PREVIOUS Chronic infection? (a.) YES—-(b.) NO----- (16B) Known Hypertensive Yes [ ], NO [ ] (18). FINDINGS AT CLINICAL EXAMINATION AT RECRUITMENT AND AT DISCHARGE ? TICK [√] below: VARIABLE AT RECRUITEMNT PRESENCE ABSENCE VAS SCORE VARIABLE At 4 weeks/discharge PRESENCE ABSENCE VAS SCORE Expectoration Expectoration Nasal discharge Nasal discharge Fever Fever Sore throat Sore throat Headache Headache Cough Cause Earache Earache Malaise/fatigue Malaise/fatigue Sleep disturbance Sleep disturbance Diarrhea Diarrhea 19. SOME LABORATORY PARAMETERS LABORATORY VARIABLE VALUES AT BASELINE VALUES IN DISCHARGE NORMAL RANGES HIV HBV HCV Na K Bicarbonate Chloride AST ALP ALT Bilirubin PCV or HCT Hb Wbc Platelets ANTIBODY TESTING
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Recruitment status	08/07/2022	The trial has been completed	Not yet recruiting	Completed

Pan African Clinical Trials Registry