Official Title
Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment
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).

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.

Completed
COVID 19

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)

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Pakistan
Locations

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

Shehnoor Azhar
NCT Number
MeSH Terms
COVID-19
Azithromycin
Hydroxychloroquine
Oseltamivir