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

Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment

Sponsors

Lead Sponsor: Shehnoor Azhar

Source University of Health Sciences Lahore
Brief Summary

To evaluate the effectiveness of Hydroxychloroquine Phosphate/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 Phosphate/Sulfate alone (control intervention) vs a series of alternatives (comparator interventions) including Oseltamivir and Azithromycin alone and in combination with Hydroxychloroquine Phosphate/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.

Overall Status Recruiting
Start Date April 22, 2020
Completion Date November 30, 2020
Primary Completion Date September 1, 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Laboratory Result Day 07 on follow-up
Clinical Outcome Day 07 on follow-up
Enrollment 500
Condition
Intervention

Intervention Type: Drug

Intervention Name: Hydroxychloroquine

Description: Hydroxychloroquine Phosphate/Sulfate (200 mg orally thrice a day for 5 days)

Intervention Type: Drug

Intervention Name: Oseltamivir

Description: Oseltamivir (75 mg orally twice a day for 5 days)

Intervention Type: Drug

Intervention Name: Azithromycin

Description: 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Javed Akram, FRCP Principal Investigator University of Health Sciences Lahore
Overall Contact

Last Name: Shehnoor Azhar, MPH

Phone: +92 321 4090221

Email: [email protected]

Location
Facility: Status: Contact:
Faislabad Medical University | Faisalābad, Pakistan Recruiting Hanif Nagra
Gujranwala Medical College | Gujrānwāla, Pakistan Recruiting Maroof Aziz
Nawaz Sharif Medical College | Gujrāt, Pakistan Recruiting
Szabmu-Pims | Islamabad, Pakistan Recruiting Tanweer Khaliq
Akram Medical Complex | Lahore, Pakistan Recruiting Shehla Javed
Fatima Jinnah Medical University | Lahore, Pakistan Recruiting Aamir Zaman
King Edward Medical University-Mayo Hospital | Lahore, Pakistan Recruiting Khalid M Gondal
Lahore General Hospital | Lahore, Pakistan Recruiting Farah Sadiq
Khyber Teaching Hospital | Peshawar, Pakistan Recruiting Saadia Ashraf
Rawalpindi Medical University | Rawalpindi, Pakistan Recruiting Muhammad Umar
Sargodha Medical College | Sargodha, Pakistan Recruiting Saifullah Goraya
Location Countries

Pakistan

Verification Date

July 2020

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: University of Health Sciences Lahore

Investigator Full Name: Shehnoor Azhar

Investigator Title: Study Coordinator

Has Expanded Access No
Number Of Arms 8
Arm Group

Label: Control Intervention

Type: Active Comparator

Description: Hydroxychloroquine

Label: Comparator 1

Type: Experimental

Description: Azithromycin

Label: Comparator 2

Type: Experimental

Description: Oseltamivir

Label: Comparator 3

Type: Experimental

Description: Hydroxychloroquine + Azithromycin

Label: Comparator 4

Type: Experimental

Description: Hydroxychloroquine + Oseltamivir

Label: Comparator 5

Type: Experimental

Description: Oseltamivir + Azithromycin

Label: Comparator 6

Type: Experimental

Description: Hydroxyquinine + Oseltamivir + Azithromycin

Label: Observational Cohort

Type: No Intervention

Description: Non-consenting to randomization

Acronym PROTECT
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Adaptive design (sample size given below is indicative)

Primary Purpose: Treatment

Masking: Double (Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov