Hydroxychloroquine, Oseltamivir and Azithromycin for the Treatment of COVID-19 Infection: An RCT (PROTECT)
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ClinicalTrials.gov Identifier: NCT04338698 |
Recruitment Status :
Completed
First Posted : April 8, 2020
Last Update Posted : February 10, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID 19 | Drug: Hydroxychloroquine Drug: Oseltamivir Drug: Azithromycin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 550 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Adaptive design (sample size given below is indicative) |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment |
Actual Study Start Date : | April 22, 2020 |
Actual Primary Completion Date : | November 15, 2020 |
Actual Study Completion Date : | November 22, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Control Intervention
Hydroxychloroquine
|
Drug: Hydroxychloroquine
Hydroxychloroquine Sulfate (200 mg orally thrice a day for 5 days) |
Experimental: Comparator 1
Azithromycin
|
Drug: Azithromycin
Azithromycin (500 mg orally once a day on day 1, followed by 250 mg orally daily on days 2-5) |
Experimental: Comparator 2
Oseltamivir
|
Drug: Oseltamivir
Oseltamivir (75 mg orally twice a day for 5 days) |
Experimental: Comparator 3
Hydroxychloroquine + Azithromycin
|
Drug: Hydroxychloroquine
Hydroxychloroquine Sulfate (200 mg orally thrice a day for 5 days) Drug: Azithromycin Azithromycin (500 mg orally once a day on day 1, followed by 250 mg orally daily on days 2-5) |
Experimental: Comparator 4
Hydroxychloroquine + Oseltamivir
|
Drug: Hydroxychloroquine
Hydroxychloroquine Sulfate (200 mg orally thrice a day for 5 days) Drug: Oseltamivir Oseltamivir (75 mg orally twice a day for 5 days) |
Experimental: Comparator 5
Oseltamivir + Azithromycin
|
Drug: Oseltamivir
Oseltamivir (75 mg orally twice a day for 5 days) Drug: Azithromycin Azithromycin (500 mg orally once a day on day 1, followed by 250 mg orally daily on days 2-5) |
Experimental: Comparator 6
Hydroxyquinine + Oseltamivir + Azithromycin
|
Drug: Hydroxychloroquine
Hydroxychloroquine Sulfate (200 mg orally thrice a day for 5 days) Drug: Oseltamivir Oseltamivir (75 mg orally twice a day for 5 days) Drug: Azithromycin Azithromycin (500 mg orally once a day on day 1, followed by 250 mg orally daily on days 2-5) |
No Intervention: Observational Cohort
Non-consenting to randomization
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- Laboratory Result [ Time Frame: Day 07 on follow-up ]The laboratory-based primary outcome will be turning test negative for COVID-19 on RT-qPCR calculated as viral load of < 150 i.u
- Clinical Outcome [ Time Frame: Day 07 on follow-up ]
The clinical primary outcome will be improvement of two points on a seven-category ordinal scale shown below:
- Not hospitalized, able to resume normal activities
- Not hospitalized, but unable to resume normal activities
- Hospitalization, not requiring supplemental oxygen
- Hospitalization, requiring supplemental oxygen
- Hospitalization, requiring noninvasive mechanical ventilation
- Hospitalization, requiring invasive mechanical ventilation
- Death

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Confirmed SARS-CoV-2 (COVID-19) infection by a positive test result
- Either gender
- Symptomatic for example fever, dry Cough, difficulty to breathe
Exclusion Criteria:
- Confirmed absence of SARS-CoV-2 (COVID-19) infection by a negative test result
- Have chronic conditions such as heart disease, liver and kidney failure
- Pregnant or currently lactating
- Immunocompromise and/or systemic disease(s)
- On other antiviral drugs
- History of allergy to any of the drugs to be administered in this study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04338698
Pakistan | |
Faislabad Medical University | |
Faisalābad, Pakistan | |
Gujranwala Medical College | |
Gujrānwāla, Pakistan | |
Nawaz Sharif Medical College | |
Gujrāt, Pakistan | |
Szabmu-Pims | |
Islamabad, Pakistan | |
Akram Medical Complex | |
Lahore, Pakistan | |
Fatima Jinnah Medical University | |
Lahore, Pakistan | |
King Edward Medical University-Mayo Hospital | |
Lahore, Pakistan | |
Lahore General Hospital | |
Lahore, Pakistan | |
Khyber Teaching Hospital | |
Peshawar, Pakistan | |
Rawalpindi Medical University | |
Rawalpindi, Pakistan | |
Sargodha Medical College | |
Sargodha, Pakistan |
Principal Investigator: | Javed Akram, FRCP | University of Health Sciences Lahore |
Responsible Party: | Shehnoor Azhar, Study Coordinator, University of Health Sciences Lahore |
ClinicalTrials.gov Identifier: | NCT04338698 |
Other Study ID Numbers: |
12(06)/2016-Coord |
First Posted: | April 8, 2020 Key Record Dates |
Last Update Posted: | February 10, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | On completion of study, investigators are open to participation in planned IPD projects with a prospective registration, subject to appropriate approvals |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |
Azithromycin Hydroxychloroquine Oseltamivir Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents Antiviral Agents |