Clinical trial NCT04338698: Hydroxychloroquine, Oseltamivir and Azithromycin for the Treatment of COVID-19 Infection: An RCT
Official title: Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID 19
Lead sponsor: University of Health Sciences Lahore
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adaptive design (sample size given below is indicative)
Primary purpose: 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.

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

Primary outcomes:
measure: Laboratory Result
timeFrame: Day 07 on follow-up
measure: Clinical Outcome
timeFrame: Day 07 on follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Faislabad Medical University
city: Gujrānwāla
country: Pakistan
facility: Gujranwala Medical College
city: Gujrāt
country: Pakistan
facility: Nawaz Sharif Medical College
city: Islamabad
country: Pakistan
facility: Szabmu-Pims
city: Lahore
country: Pakistan
facility: Akram Medical Complex
city: Lahore
country: Pakistan
facility: Fatima Jinnah Medical University
city: Lahore
country: Pakistan
facility: King Edward Medical University-Mayo Hospital
city: Lahore
country: Pakistan
facility: Lahore General Hospital
city: Peshawar
country: Pakistan
facility: Khyber Teaching Hospital
city: Rawalpindi
country: Pakistan
facility: Rawalpindi Medical University
city: Sargodha
country: Pakistan
facility: Sargodha Medical College
Study officials:
affiliation: University of Health Sciences Lahore
name: Javed Akram, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Azhar S, Akram J, Shahzad M, Latif W, Khan KS. Protocol of Pakistan randomized and observational trial to evaluate coronavirus treatment among newly diagnosed patients with COVID-19: Azithromycin, Oseltamivir, and Hydroxychloquine. Pak J Med Sci. 2022 May-Jun;38(5):1401-1408. doi: 10.12669/pjms.38.5.5512.
citation: Akram J, Azhar S, Shahzad M, Latif W, Khan KS. Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment (PROTECT) of Hydroxychloroquine, Oseltamivir and Azithromycin to treat newly diagnosed patients with COVID-19 infection who have no comorbidities like diabetes mellitus: A structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Aug 8;21(1):702. doi: 10.1186/s13063-020-04616-4.