PROTECT: Hydroxychloroquine, Oseltamivir and Azithromycin for the Treatment of COVID-19 Infection: An RCT
Study Details
Study Description
Brief Summary
To evaluate the effectiveness of Hydroxychloroquine Sulfate (200 mg orally 8hr thrice a day for 5 days) vs oseltamivir (75 mg orally twice a day for 5 days) vs Azithromycin (500 mg orally daily on day 1, followed by 250 mg orally twice a day on days 2-5) alone and in combination (in all seven groups), in clearing the coronavirus nucleic acid from throat and nasal swab and in bringing about clinical improvement on day 7 of follow-up (primary outcomes).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Detailed Description
A scientific taskforce notified by the Ministry of Science and Technology of the Government of Pakistan will oversee a comprehensive cohort study. Within this cohort, a multicenter, adaptive, randomized controlled trial will evaluate, among eligible SARS-Cov-2 (COVID-19) infected patients receiving standard supportive care who consent to randomization following a new diagnosis in Pakistan, if Hydroxychloroquine Sulfate alone (control intervention) vs a series of alternatives (comparator interventions) including Oseltamivir and Azithromycin alone and in combination with Hydroxychloroquine Sulfate is effective in clearing the coronavirus and improving the clinical course of the disease. Those not consenting to randomization will be followed up for outcomes of SARS-Cov-2 infection with supportive care only. Findings of this study are expected to inform clinical care and public health protocols and policies for management of SARS-Cov-2.
Study Design
Arms and Interventions
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 |
Outcome Measures
Primary Outcome Measures
- Laboratory Result [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 [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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Faislabad Medical University | Faisalābad | Pakistan | ||
2 | Gujranwala Medical College | Gujrānwāla | Pakistan | ||
3 | Nawaz Sharif Medical College | Gujrāt | Pakistan | ||
4 | Szabmu-Pims | Islamabad | Pakistan | ||
5 | Akram Medical Complex | Lahore | Pakistan | ||
6 | Fatima Jinnah Medical University | Lahore | Pakistan | ||
7 | King Edward Medical University-Mayo Hospital | Lahore | Pakistan | ||
8 | Lahore General Hospital | Lahore | Pakistan | ||
9 | Khyber Teaching Hospital | Peshawar | Pakistan | ||
10 | Rawalpindi Medical University | Rawalpindi | Pakistan | ||
11 | Sargodha Medical College | Sargodha | Pakistan |
Sponsors and Collaborators
- Shehnoor Azhar
Investigators
- Principal Investigator: Javed Akram, FRCP, University of Health Sciences Lahore
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 12(06)/2016-Coord