Hydroxychloroquine, Oseltamivir and Azithromycin for the Treatment of COVID-19 Infection: An RCT

Phase 3

Completed

• Conditions: COVID 19
• Interventions: Drug: Hydroxychloroquine; Drug: Azithromycin; Drug: Oseltamivir

• Registration Number: NCT04338698
• Lead Sponsor: Shehnoor Azhar

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.

Study Timeline

• Study First Submitted: 2020-04-04
• Study First Submitted QC: 2020-04-04
• Study First Posted: 2020-04-08
• Study Start: 2020-04-22
• Primary Completion: 2020-11-15
• Study Completion: 2020-11-22
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Intervention	Hydroxychloroquine	Hydroxychloroquine
Comparator 1	Azithromycin	Azithromycin
Comparator 2	Oseltamivir	Oseltamivir
Comparator 3	Hydroxychloroquine	Hydroxychloroquine + Azithromycin
Comparator 6	Azithromycin	Hydroxyquinine + Oseltamivir + Azithromycin
Comparator 6	Oseltamivir	Hydroxyquinine + Oseltamivir + Azithromycin
Comparator 4	Hydroxychloroquine	Hydroxychloroquine + Oseltamivir
Comparator 3	Azithromycin	Hydroxychloroquine + Azithromycin
Comparator 4	Oseltamivir	Hydroxychloroquine + Oseltamivir
Comparator 5	Oseltamivir	Oseltamivir + Azithromycin
Comparator 5	Azithromycin	Oseltamivir + Azithromycin
Comparator 6	Hydroxychloroquine	Hydroxyquinine + Oseltamivir + Azithromycin

Primary Outcome Measures

Name	Time	Method
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: 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

Trial Locations

Locations (11)

Gujranwala Medical College; 🇵🇰 Gujrānwāla, Pakistan

Khyber Teaching Hospital; 🇵🇰 Peshawar, Pakistan

Akram Medical Complex; 🇵🇰 Lahore, Pakistan

Fatima Jinnah Medical University; 🇵🇰 Lahore, Pakistan

Sargodha Medical College; 🇵🇰 Sargodha, Pakistan

Szabmu-Pims; 🇵🇰 Islamabad, Pakistan

Faislabad Medical University; 🇵🇰 Faisalābad, Pakistan

Nawaz Sharif Medical College; 🇵🇰 Gujrāt, Pakistan

King Edward Medical University-Mayo Hospital; 🇵🇰 Lahore, Pakistan

Lahore General Hospital; 🇵🇰 Lahore, Pakistan

Rawalpindi Medical University; 🇵🇰 Rawalpindi, Pakistan