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

Sponsor
Shehnoor Azhar (Other)
Overall Status
Completed
CT.gov ID
NCT04338698
Collaborator
(none)
550
11
8
7
50
7.1

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
550 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Adaptive design (sample size given below is indicative)Adaptive design (sample size given below is indicative)
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment
Actual Study Start Date :
Apr 22, 2020
Actual Primary Completion Date :
Nov 15, 2020
Actual Study Completion Date :
Nov 22, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control Intervention

Hydroxychloroquine

Drug: Hydroxychloroquine
Hydroxychloroquine Sulfate (200 mg orally thrice a day for 5 days)

Experimental: Comparator 1

Azithromycin

Drug: Azithromycin
Azithromycin (500 mg orally once a day on day 1, followed by 250 mg orally daily on days 2-5)

Experimental: Comparator 2

Oseltamivir

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

Experimental: Comparator 3

Hydroxychloroquine + Azithromycin

Drug: Hydroxychloroquine
Hydroxychloroquine Sulfate (200 mg orally thrice a day for 5 days)

Drug: Azithromycin
Azithromycin (500 mg orally once a day on day 1, followed by 250 mg orally daily on days 2-5)

Experimental: Comparator 4

Hydroxychloroquine + Oseltamivir

Drug: Hydroxychloroquine
Hydroxychloroquine Sulfate (200 mg orally thrice a day for 5 days)

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

Experimental: Comparator 5

Oseltamivir + Azithromycin

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

Drug: Azithromycin
Azithromycin (500 mg orally once a day on day 1, followed by 250 mg orally daily on days 2-5)

Experimental: Comparator 6

Hydroxyquinine + Oseltamivir + Azithromycin

Drug: Hydroxychloroquine
Hydroxychloroquine Sulfate (200 mg orally thrice a day for 5 days)

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

Drug: Azithromycin
Azithromycin (500 mg orally once a day on day 1, followed by 250 mg orally daily on days 2-5)

No Intervention: Observational Cohort

Non-consenting to randomization

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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: 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faislabad Medical University Faisalābad Pakistan
2 Gujranwala Medical College Gujrānwāla Pakistan
3 Nawaz Sharif Medical College Gujrāt Pakistan
4 Szabmu-Pims Islamabad Pakistan
5 Akram Medical Complex Lahore Pakistan
6 Fatima Jinnah Medical University Lahore Pakistan
7 King Edward Medical University-Mayo Hospital Lahore Pakistan
8 Lahore General Hospital Lahore Pakistan
9 Khyber Teaching Hospital Peshawar Pakistan
10 Rawalpindi Medical University Rawalpindi Pakistan
11 Sargodha Medical College Sargodha Pakistan

Sponsors and Collaborators

  • Shehnoor Azhar

Investigators

  • Principal Investigator: Javed Akram, FRCP, University of Health Sciences Lahore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shehnoor Azhar, Study Coordinator, University of Health Sciences Lahore
ClinicalTrials.gov Identifier:
NCT04338698
Other Study ID Numbers:
  • 12(06)/2016-Coord
First Posted:
Apr 8, 2020
Last Update Posted:
Feb 10, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2022