COVID 19Phase 2CHEERNCT04359537
Efficacy of Various Doses of Hydroxychloroquine in Pre-Exposure Prophylaxis for COVID 19
A Phase 2 study testing Hydroxychloroquine Sulfate 200 MG in people with COVID 19, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial summary
Hydroxychloroquine has been approved by FDA as one of the treatment options for COVID 19.Healthcare personnel are amongst those at highest risk to contract the disease. Several health authorities are now recommending the use of hydroxychloroquine as pre-exposure prophylaxis is in health care personnel. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- COVID 19
- What is being tested?
- Hydroxychloroquine Sulfate 200 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2020to 25 Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A healthcare worker at high risk for COVID19 exposure (defined below):
- Persons primarily working in emergency departments (physicians, nurses, ancillary staff, triage personnel) ;
- Persons primarily working in intensive care units (physicians, nurses, ancillary staff, respiratory therapists) ;
- Persons performing aerosol generating procedures (i.e. anesthesiologists, nurse anesthetists, gastroenterologists performing endoscopy, Pulmonologists performing bronchoscopy);
- First responders (i.e. EMTs, paramedics) ;
- Persons working in the departments of General Medicine, Pulmonology, Infectious disease and Isolation wards.
Who cannot join
- Active COVID-19 disease;
- Confirmed prior COVID-19 disease;
- Current fever, cough, shortness of breath;
- Contraindication or hypersensitivity to chloroquine or hydroxychloroquine ad hypersensitivity to 4-aminoquinoline compounds;
- Pregnancy;
- Lactation;
Show all 15Show fewer
- Prior retinal eye disease;
- Known Chronic Kidney disease, Stage 4 or 5 or dialysis;
- Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency ;
- Weight <40 kg;
- Current use of chloroquine,hydroxychloroquine or cardiac medicines like flecainide, amiodarone, digoxin, procainamide, or propafenone;
- Current use of medications with known significant drug-drug interactions: artemether, lumefantrine, mefloquine, tamoxifen or methotrexate;
- Current use of medications causing QT interval prolongation like: macrolides,antipsychotics,quinolones,antihistamines,SSRIs,tricyclic antidepressants, antifungals;
- Recent Myocardial Infarction;
- History of Epilepsy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shaheed Zulfiaqar Ali Bhutto Medical University
Islamabad, Federal Capital, 44000
Fibhaa Syed, FRCP, +923335300002 ext. +923335300002, fibhaasyed@gmail.com
Mohammed Ali Ali Arif, FRCP, +923335123701, mohammad_ali_arif@hotmail.com
About this study
Official title: Comparative Efficacy of Various Doses of Hydroxychloroquine in Pre-Exposure Prophylaxis for COVID 19 in Healthcare Personnel
Hydroxychloroquine has been approved by FDA as one of the treatment options for COVID 19.Healthcare personnel are amongst those at highest risk to contract the disease. Several health authorities are now recommending the use of hydroxychloroquine as pre-exposure prophylaxis is in health care personnel. Several studies are on going in this context. However there is a controversy regarding the dosage regimen. This drug has a half life of 22.4 days. In this study we will be comparing three different doses of Hydroxychloroquine and additionally have a control group in order to determine the efficacy of hydroxychloroquine as pre- exposure prophylaxis in healthcare personnel in various doses.
Read the detailed description
Study design:
Phase 2 proof of concept study Study Type: Interventional (Clinical Trial) Estimated Enrollment : at least 200 participants Since the investigators have no current data on pre-exposure prophylaxis to calculate sample size statistically, so a minimum of 50 participants in each arm will be recruited including 20% attrition rate. The investigators will be recruiting a minimum of 200 participants in the study , that is at least 50 in each of the four arms.
Allocation: Randomized Intervention Model: Parallel Assignment Study model: Parallel group interventional study Location: SZABMU/PIMS Study duration: a minimum of 12 weeks from recruitment
Materials and Methods:
Participants will be recruited after approval from Ethical Review Board .A written informed consent will be taken from all participants. Participants fulfilling the eligibility criteria will be randomized to 4 arms.
Arm Intervention /treatment
Experimental group 1: Hydroxychloroquine 400 mg twice a day 1,followed by 400 mg weekly for a total of 12 weeks Drug: Hydroxychloroquin HCQ 200 mg, oral
Experimental group 2:Hydroxychloroquine 400 mg on day 1 followed by 400mg once every 3 weeks for a total of 12 weeks Drug: Hydroxychloroquin HCQ 200 mg, oral
Experimental group 3:Hydroxychloroquine 200 mg on day 1 followed by 200 mg once every 3 weeks for a total of 12 weeks Drug: Hydroxychloroquin HCQ 200 mg, oral
Control Group : Placebo 200mg will be given on day 1 followed by Placebo 200mg every three weeks for a total of 12 weeks.
Base line characteristics of all participants will be recorded including age ,gender,role of healthcare personnel, comorbidities, and drugs the participant is using.
Samples will be collected for complete picture blood, liver and renal function tests and electrocardiogram. These tests will also be conducted every month till the end of the trial and the participants will be monitored for any adverse effects.
During the study duration all participants will self- report any symptoms related to COVID 19 and any adverse reactions from the drug. Participants having COVID 19 symptoms at any time will be tested by the gold standard test PCR for SARS-COV-2 using nasopharyngeal and oropharyngeal swabs.
All participants at the end of the study will have PCR for SARS-COV-2 and if available IgM and IgG serology to find out if they had any infection, did not get infected at all or only had asymptomatic or mild infection.
- Conditions
- COVID 19
- Being tested
- Hydroxychloroquine Sulfate 200 MG, Placebo
- Keywords
- pre-exposure prophylaxis, Healthcare personnel
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine Sulfate 200 MGDrug
Also called Tab HCQ
Hydroxychloroquine Sulphate 200 mg tablets will be prescribed and instituted orally at the doses and regimens described
PlaceboOther
Control group will receive a Placebo tablet. Placebo 200mg will be given on Day 1 followed by Placebo 200mg every three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Hydroxychloroquine Sulphate will be administered at a dose of 400mg twice a day on day 1 followed by 400 mg once a week for a total of 12 weeks Receives: Drug: Hydroxychloroquine Sulfate 200 MG |
| Arm 2 | Experimental | Hydroxychloroquine Sulphate will be admoinistered at a dose of 400 mg on day 1 followed by 400mg once every 3 weeks for at total of 12 weeks Receives: Drug: Hydroxychloroquine Sulfate 200 MG |
| Arm 3 | Experimental | Hydroxychloroquine Sulphate will be administered at a dose of 200 mg on day 1 followed by 200 mg once every 3 weeks for a total of 12 weeks Receives: Drug: Hydroxychloroquine Sulfate 200 MG |
| Arm 4 | Placebo comparator | Control group will recieve Placebo 200mg on day 1 followed by Placebo 200mg every three weeks for 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19-free survival in experimental arms compared to placebo
Outcome reported as the percentage of participants in each arm who are COVID-19-free at the end of study treatment
Measured: 12 weeks
Secondary outcomes (6)
Incidence of confirmed SARS-COV-2 detection
Outcome reported as the percent of participants in each arm who have a confirmed SARS-CoV-2 infection during study treatment.
Measured: 12 weeks
Incidence of possible COVID-19 symptoms
Outcome reported as the percent of participants in each arm who report COVID-19-related symptoms during study treatment
Measured: 12 weeks
Incidence of all-cause study medicine discontinuation
Outcome reported as the percent of participants in each arm who discontinue study medication use for any reason during treatment.
Measured: 12 weeks
Ordinal Scale of COVID-19 Disease maximum severity if COVID-19 diagnosed at study end
Participants will self-report COVID-19 status on an ordinal scale as follows: No illness (score=1), Illness with outpatient observation (score=2), Hospitalization (or post-hospital discharge) (score=3), Hospitalization with ICU stay (score 4),Death from COVID 19(score=5) Possible scores range from 1-5 with higher scores indicating greater disease severity.
Measured: 12 weeks
Incidence of Hospitalization for COVID-19 or death
Outcome reported as the percent of participants in each arm who are hospitalized or expire due to COVID-19 during study treatment.
Measured: 12 weeks
Incidence of study medication-related adverse events
Outcome reported as the percent of participants experiencing any possible adverse events from Hydroxychloroquine
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 May 2020
- Primary completion25 Aug 2020 (estimated)
- Study completion25 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants fulfilling the eligibility criteria will be randomized to 4 arms by using Random Allocation Software version-2 Arm Intervention /treatment Experimental group 1: Hydroxychloroquine 400 mg twice a day 1,followed by 400 mg weekly for a total of 12 weeks Experimental group 2:Hydroxychloroquine 400 mg on day 1 followed by 400 mg once every 3 weeks for a total of 12 weeks Experimental group 3:Hydroxychloroquine 200 mg on day 1 followed by 200 mg once every 3 weeks for a total of 12 weeks Control Group :Placebo 200mg will be given on day 1 followed by Placebo 200mg every three weeks for a total of 12 weeks..
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fibhaa Syed, Shaheed Zulfiqar Ali Bhutto Medical University
- Investigators
- Fibhaa Syed, FRCP, Principal investigator, Shaheed Zylfiqar Ali Bhutto Medical UniversityMohammed Ali Arif, FRCP, Principal investigator, Shaheed Zulfiqar Ali Bhutto Medical UniversityRauf Niazi, FRCP, Study director, Shaheed Zulfiqar Ali Bhutto Medical University /PIMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359537
- Sponsor's protocol ID
- F.1-1/2015/ERB/SZABMU/549
- Acronym
- CHEER
- Status last verified
- May 2020
- First submitted
- 20 Apr 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Sevestre J, Mailhe M, Doudier B, Aubry C, Amrane S, Seng P, Hocquart M, Eldin C, Finance J, Vieira VE, Tissot-Dupont HT, Honore S, Stein A, Million M, Colson P, La Scola B, Veit V, Jacquier A, Deharo JC, Drancourt M, Fournier PE, Rolain JM, Brouqui P, Raoult D. Clinical and microbiological effect of a combination of hydroxychloroquine and azithromycin in 80 COVID-19 patients with at least a six-day follow up: A pilot observational study. Travel Med Infect Dis. 2020 Mar-Apr;34:101663. doi: 10.1016/j.tmaid.2020.101663. Epub 2020 Apr 11.
PubMed 32289548Mack HG. Hydroxychloroquine use during the COVID-19 pandemic 2020. Aust J Gen Pract. 2020 Apr 14;49. doi: 10.31128/AJGP-COVID-08.
PubMed 32294807Xiang YT, Jin Y, Wang Y, Zhang Q, Zhang L, Cheung T. Tribute to health workers in China: A group of respectable population during the outbreak of the COVID-19. Int J Biol Sci. 2020 Mar 15;16(10):1739-1740. doi: 10.7150/ijbs.45135. eCollection 2020.
PubMed 32226292Khan S, Siddique R, Ali A, Bai Q, Li Z, Li H, Shereen MA, Xue M, Nabi G. The spread of novel coronavirus has created an alarming situation worldwide. J Infect Public Health. 2020 Apr;13(4):469-471. doi: 10.1016/j.jiph.2020.03.005. Epub 2020 Apr 2. No abstract available.
PubMed 32247752
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Various Doses of Hydroxychloroquine in Pre-Exposure Prophylaxis for COVID 19 in Healthcare Personnel
- ClinicalTrials.gov ID
- NCT04359537
- Acronym / sponsor ID
- CHEER / F.1-1/2015/ERB/SZABMU/549
- Conditions
- COVID 19
- Keywords
- pre-exposure prophylaxis, Healthcare personnel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 25 Aug 2020 (estimated)
- Study completion
- 25 Sep 2020 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hydroxychloroquine has been approved by FDA as one of the treatment options for COVID 19.Healthcare personnel are amongst those at highest risk to contract the disease. Several health authorities are now recommending the use of hydroxychloroquine as pre-exposure prophylaxis is in health care personnel. Several studies are on going in this context. However there is a controversy regarding the dosage regimen. This drug has a half life of 22.4 days. In this study we will be comparing three different doses of Hydroxychloroquine and additionally have a control group in order to determine the efficacy of hydroxychloroquine as pre- exposure prophylaxis in healthcare personnel in various doses.
Detailed description
Study design:
Phase 2 proof of concept study Study Type: Interventional (Clinical Trial) Estimated Enrollment : at least 200 participants Since the investigators have no current data on pre-exposure prophylaxis to calculate sample size statistically, so a minimum of 50 participants in each arm will be recruited including 20% attrition rate. The investigators will be recruiting a minimum of 200 participants in the study , that is at least 50 in each of the four arms.
Allocation: Randomized Intervention Model: Parallel Assignment Study model: Parallel group interventional study Location: SZABMU/PIMS Study duration: a minimum of 12 weeks from recruitment
Materials and Methods:
Participants will be recruited after approval from Ethical Review Board .A written informed consent will be taken from all participants. Participants fulfilling the eligibility criteria will be randomized to 4 arms.
Arm Intervention /treatment
Experimental group 1: Hydroxychloroquine 400 mg twice a day 1,followed by 400 mg weekly for a total of 12 weeks Drug: Hydroxychloroquin HCQ 200 mg, oral
Experimental group 2:Hydroxychloroquine 400 mg on day 1 followed by 400mg once every 3 weeks for a total of 12 weeks Drug: Hydroxychloroquin HCQ 200 mg, oral
Experimental group 3:Hydroxychloroquine 200 mg on day 1 followed by 200 mg once every 3 weeks for a total of 12 weeks Drug: Hydroxychloroquin HCQ 200 mg, oral
Control Group : Placebo 200mg will be given on day 1 followed by Placebo 200mg every three weeks for a total of 12 weeks.
Base line characteristics of all participants will be recorded including age ,gender,role of healthcare personnel, comorbidities, and drugs the participant is using.
Samples will be collected for complete picture blood, liver and renal function tests and electrocardiogram. These tests will also be conducted every month till the end of the trial and the participants will be monitored for any adverse effects.
During the study duration all participants will self- report any symptoms related to COVID 19 and any adverse reactions from the drug. Participants having COVID 19 symptoms at any time will be tested by the gold standard test PCR for SARS-COV-2 using nasopharyngeal and oropharyngeal swabs.
All participants at the end of the study will have PCR for SARS-COV-2 and if available IgM and IgG serology to find out if they had any infection, did not get infected at all or only had asymptomatic or mild infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Participants fulfilling the eligibility criteria will be randomized to 4 arms by using Random Allocation Software version-2 Arm Intervention /treatment Experimental group 1: Hydroxychloroquine 400 mg twice a day 1,followed by 400 mg weekly for a total of 12 weeks Experimental group 2:Hydroxychloroquine 400 mg on day 1 followed by 400 mg once every 3 weeks for a total of 12 weeks Experimental group 3:Hydroxychloroquine 200 mg on day 1 followed by 200 mg once every 3 weeks for a total of 12 weeks Control Group :Placebo 200mg will be given on day 1 followed by Placebo 200mg every three weeks for a total of 12 weeks..
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Hydroxychloroquine Sulfate 200 MGHydroxychloroquine Sulphate will be administered at a dose of 400mg twice a day on day 1 followed by 400 mg once a week for a total of 12 weeks |
| Arm 2 | Experimental | Drug: Hydroxychloroquine Sulfate 200 MGHydroxychloroquine Sulphate will be admoinistered at a dose of 400 mg on day 1 followed by 400mg once every 3 weeks for at total of 12 weeks |
| Arm 3 | Experimental | Drug: Hydroxychloroquine Sulfate 200 MGHydroxychloroquine Sulphate will be administered at a dose of 200 mg on day 1 followed by 200 mg once every 3 weeks for a total of 12 weeks |
| Arm 4 | Placebo comparator | Other: PlaceboControl group will recieve Placebo 200mg on day 1 followed by Placebo 200mg every three weeks for 12 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- A healthcare worker at high risk for COVID19 exposure (defined below):
Key exclusion criteria (15 listed)
- Active COVID-19 disease;
- Confirmed prior COVID-19 disease;
- Current fever, cough, shortness of breath;
- Contraindication or hypersensitivity to chloroquine or hydroxychloroquine ad hypersensitivity to 4-aminoquinoline compounds;
- Pregnancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine Sulfate 200 MGAlso: Tab HCQHydroxychloroquine Sulphate 200 mg tablets will be prescribed and instituted orally at the doses and regimens described | Drug | Arm 1, Arm 2, Arm 3 |
| PlaceboControl group will receive a Placebo tablet. Placebo 200mg will be given on Day 1 followed by Placebo 200mg every three weeks. | Other | Arm 4 |
Primary outcome
COVID-19-free survival in experimental arms compared to placebo
Time frame: 12 weeks
Outcome reported as the percentage of participants in each arm who are COVID-19-free at the end of study treatment
6 secondary outcomes
Incidence of confirmed SARS-COV-2 detection
Time frame: 12 weeks
Incidence of possible COVID-19 symptoms
Time frame: 12 weeks
Incidence of all-cause study medicine discontinuation
Time frame: 12 weeks
Ordinal Scale of COVID-19 Disease maximum severity if COVID-19 diagnosed at study end
Time frame: 12 weeks
Incidence of Hospitalization for COVID-19 or death
Time frame: 12 weeks
Incidence of study medication-related adverse events
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Background: PubMed 32289548Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Sevestre J, Mailhe M, Doudier B, Aubry C, Amrane S, Seng P, Hocquart M, Eldin C, Finance J, Vieira VE, Tissot-Dupont HT, Honore S, Stein A, Million M, Colson P, La Scola B, Veit V, Jacquier A, Deharo JC, Drancourt M, Fournier PE, Rolain JM, Brouqui P, Raoult D. Clinical and microbiological effect of a combination of hydroxychloroquine and azithromycin in 80 COVID-19 patients with at least a six-day follow up: A pilot observational study. Travel Med Infect Dis. 2020 Mar-Apr;34:101663. doi: 10.1016/j.tmaid.2020.101663. Epub 2020 Apr 11.
- Background: PubMed 32294807Mack HG. Hydroxychloroquine use during the COVID-19 pandemic 2020. Aust J Gen Pract. 2020 Apr 14;49. doi: 10.31128/AJGP-COVID-08.
- Background: PubMed 32226292Xiang YT, Jin Y, Wang Y, Zhang Q, Zhang L, Cheung T. Tribute to health workers in China: A group of respectable population during the outbreak of the COVID-19. Int J Biol Sci. 2020 Mar 15;16(10):1739-1740. doi: 10.7150/ijbs.45135. eCollection 2020.
- Background: PubMed 32247752Khan S, Siddique R, Ali A, Bai Q, Li Z, Li H, Shereen MA, Xue M, Nabi G. The spread of novel coronavirus has created an alarming situation worldwide. J Infect Public Health. 2020 Apr;13(4):469-471. doi: 10.1016/j.jiph.2020.03.005. Epub 2020 Apr 2. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fibhaa Syed, FRCP principal investigator
Shaheed Zylfiqar Ali Bhutto Medical University
Mohammed Ali Arif, FRCP principal investigator
Shaheed Zulfiqar Ali Bhutto Medical University
Rauf Niazi, FRCP study director
Shaheed Zulfiqar Ali Bhutto Medical University /PIMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine Sulfate 200 MG in people with COVID 19, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fibhaa Syed, FRCP (+923335300002 ext. +923335300002, drfibhasyed@szabmu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19-free survival in experimental arms compared to placebo (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04359537, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.