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

COVID 19 Clinical Trial

— PROTECT  

Official title:

Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04338698
• Other study ID #: 12(06)/2016-Coord
• Status: Completed
• Phase: Phase 3
• Start date: April 22, 2020
• Est. completion date: November 22, 2020

Study information

• Verified date: January 2022
• Source: University of Health Sciences Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: November 22, 2020
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID 19
• COVID-19

Intervention

Drug:
• Hydroxychloroquine
Hydroxychloroquine Sulfate (200 mg orally thrice a day for 5 days)
• Oseltamivir
Oseltamivir (75 mg orally twice a day for 5 days)
• Azithromycin
Azithromycin (500 mg orally once a day on day 1, followed by 250 mg orally daily on days 2-5)

Locations

Country	Name	City	State
Pakistan	Faislabad Medical University	Faisalabad
Pakistan	Gujranwala Medical College	Gujranwala
Pakistan	Nawaz Sharif Medical College	Gujrat
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

Sponsors (1)

Lead Sponsor	Collaborator
Shehnoor Azhar

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory Result	The laboratory-based primary outcome will be turning test negative for COVID-19 on RT-qPCR calculated as viral load of < 150 i.u	Day 07 on follow-up
Primary	Clinical Outcome	The clinical primary outcome will be improvement of two points on a seven-category ordinal scale shown below: Not hospitalized, able to resume normal activities; Not hospitalized, but unable to resume normal activities; Hospitalization, not requiring supplemental oxygen; Hospitalization, requiring supplemental oxygen; Hospitalization, requiring noninvasive mechanical ventilation; Hospitalization, requiring invasive mechanical ventilation; Death	Day 07 on follow-up