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

Shehnoor Azhar

Status and phase: Completed; Phase 3

Conditions: COVID 19

Treatments: Drug: Oseltamivir; Drug: Azithromycin; Drug: Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT04338698

12(06)/2016-Coord

Details and patient eligibility

About

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).

Full 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.

Enrollment: 550 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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550 participants in 8 patient groups

Control Intervention

Active Comparator group

Description:

Hydroxychloroquine

Treatment:

Drug: Hydroxychloroquine

Comparator 1

Experimental group

Description:

Azithromycin

Treatment:

Drug: Azithromycin

Comparator 2

Experimental group

Description:

Oseltamivir

Treatment:

Drug: Oseltamivir

Comparator 3

Experimental group

Description:

Hydroxychloroquine + Azithromycin

Treatment:

Drug: Azithromycin

Drug: Hydroxychloroquine

Comparator 4

Experimental group

Description:

Hydroxychloroquine + Oseltamivir

Treatment:

Drug: Oseltamivir

Drug: Hydroxychloroquine

Comparator 5

Experimental group

Description:

Oseltamivir + Azithromycin

Treatment:

Drug: Oseltamivir

Drug: Azithromycin

Comparator 6

Experimental group

Description:

Hydroxyquinine + Oseltamivir + Azithromycin

Treatment:

Drug: Oseltamivir

Drug: Azithromycin

Drug: Hydroxychloroquine

Observational Cohort

No Intervention group

Description:

Non-consenting to randomization