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.
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)
Inclusion Criteria:
1. Confirmed SARS-CoV-2 (COVID-19) infection by a positive test result
2. Either gender
3. Symptomatic for example fever, dry Cough, difficulty to breathe
Exclusion Criteria:
1. Confirmed absence of SARS-CoV-2 (COVID-19) infection by a negative test result
2. Have chronic conditions such as heart disease, liver and kidney failure
3. Pregnant or currently lactating
4. Immunocompromise and/or systemic disease(s)
5. On other antiviral drugs
6. History of allergy to any of the drugs to be administered in this study
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
Javed Akram, FRCP, Principal Investigator
University of Health Sciences Lahore