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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
550
Hydroxychloroquine Sulfate (200 mg orally thrice a day for 5 days)
Oseltamivir (75 mg orally twice a day for 5 days)
Azithromycin (500 mg orally once a day on day 1, followed by 250 mg orally daily on days 2-5)
Nawaz Sharif Medical College
Dhok Gujra, Pakistan
Faislabad Medical University
Faisalābad, Pakistan
Gujranwala Medical College
Guiranwala, Pakistan
Szabmu-Pims
Islamabad, Pakistan
Laboratory Result
The laboratory-based primary outcome will be turning test negative for COVID-19 on RT-qPCR calculated as viral load of \< 150 i.u
Time frame: Day 07 on follow-up
Clinical Outcome
The clinical primary outcome will be improvement of two points on a seven-category ordinal scale shown below: 1. Not hospitalized, able to resume normal activities 2. Not hospitalized, but unable to resume normal activities 3. Hospitalization, not requiring supplemental oxygen 4. Hospitalization, requiring supplemental oxygen 5. Hospitalization, requiring noninvasive mechanical ventilation 6. Hospitalization, requiring invasive mechanical ventilation 7. Death
Time frame: Day 07 on follow-up
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Akram Medical Complex
Lahore, Pakistan
Fatima Jinnah Medical University
Lahore, Pakistan
King Edward Medical University-Mayo Hospital
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Lahore General Hospital
Lahore, Pakistan
Khyber Teaching Hospital
Peshawar, Pakistan
Rawalpindi Medical University
Rawalpindi, Pakistan
...and 1 more locations