NCT04338698

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

April 22, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2020

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

April 4, 2020

Last Update Submit

January 27, 2022

Conditions

COVID 19

Outcome Measures

Primary Outcomes (2)

  • 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

  • Clinical Outcome

    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

    Day 07 on follow-up

Study Arms (8)

Control Intervention

ACTIVE COMPARATOR

Hydroxychloroquine

Drug: Hydroxychloroquine

Comparator 1

EXPERIMENTAL

Azithromycin

Drug: Azithromycin

Comparator 2

EXPERIMENTAL

Oseltamivir

Drug: Oseltamivir

Comparator 3

EXPERIMENTAL

Hydroxychloroquine + Azithromycin

Drug: HydroxychloroquineDrug: Azithromycin

Comparator 4

EXPERIMENTAL

Hydroxychloroquine + Oseltamivir

Drug: HydroxychloroquineDrug: Oseltamivir

Comparator 5

EXPERIMENTAL

Oseltamivir + Azithromycin

Drug: OseltamivirDrug: Azithromycin

Comparator 6

EXPERIMENTAL

Hydroxyquinine + Oseltamivir + Azithromycin

Drug: HydroxychloroquineDrug: OseltamivirDrug: Azithromycin

Observational Cohort

NO INTERVENTION

Non-consenting to randomization

Interventions

HydroxychloroquineDRUG

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

Comparator 3Comparator 4Comparator 6Control Intervention
OseltamivirDRUG

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

Comparator 2Comparator 4Comparator 5Comparator 6
AzithromycinDRUG

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

Comparator 1Comparator 3Comparator 5Comparator 6

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed SARS-CoV-2 (COVID-19) infection by a positive test result
  • Either gender
  • Symptomatic for example fever, dry Cough, difficulty to breathe

You may not qualify if:

  • Confirmed absence of SARS-CoV-2 (COVID-19) infection by a negative test result
  • Have chronic conditions such as heart disease, liver and kidney failure
  • Pregnant or currently lactating
  • Immunocompromise and/or systemic disease(s)
  • On other antiviral drugs
  • History of allergy to any of the drugs to be administered in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Nawaz Sharif Medical College

Dhok Gujra, Pakistan

Location

Faislabad Medical University

Faisalābad, Pakistan

Location

Gujranwala Medical College

Gujranwala, Pakistan

Location

Szabmu-Pims

Islamabad, Pakistan

Location

Akram Medical Complex

Lahore, Pakistan

Location

Fatima Jinnah Medical University

Lahore, Pakistan

Location

King Edward Medical University-Mayo Hospital

Lahore, Pakistan

Location

Lahore General Hospital

Lahore, Pakistan

Location

Khyber Teaching Hospital

Peshawar, Pakistan

Location

Rawalpindi Medical University

Rawalpindi, Pakistan

Location

Sargodha Medical College

Sargodha, Pakistan

Location

Related Publications (3)

  • Azhar S, Akram J, Latif W, Ibanez NC, Mumtaz S, Rafi A, Aftab U, Iqtadar S, Shahzad M, Syed F, Zafar B, Fatima N, Afridi SS, Akram SJ, Chaudhary MA, Sadiq F, Goraya S, Hanif M, Ashraf V, Ashraf S, Akram H, Khaliq T. Effectiveness of early pharmaceutical interventions in symptomatic COVID-19 patients: A randomized clinical trial. Pak J Med Sci. 2024 May-Jun;40(5):800-810. doi: 10.12669/pjms.40.5.8757.

    PMID: 38827854DERIVED

  • Azhar S, Akram J, Shahzad M, Latif W, Khan KS. Protocol of Pakistan randomized and observational trial to evaluate coronavirus treatment among newly diagnosed patients with COVID-19: Azithromycin, Oseltamivir, and Hydroxychloquine. Pak J Med Sci. 2022 May-Jun;38(5):1401-1408. doi: 10.12669/pjms.38.5.5512.

    PMID: 35799756DERIVED

  • Akram J, Azhar S, Shahzad M, Latif W, Khan KS. Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment (PROTECT) of Hydroxychloroquine, Oseltamivir and Azithromycin to treat newly diagnosed patients with COVID-19 infection who have no comorbidities like diabetes mellitus: A structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Aug 8;21(1):702. doi: 10.1186/s13063-020-04616-4.

    PMID: 32771032DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

HydroxychloroquineOseltamivirAzithromycin

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsErythromycinMacrolidesPolyketidesLactones

Study Officials

  • Javed Akram, FRCP

    University of Health Sciences Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Adaptive design (sample size given below is indicative)
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study Coordinator

Study Record Dates

First Submitted

April 4, 2020

First Posted

April 8, 2020

Study Start

April 22, 2020

Primary Completion

November 15, 2020

Study Completion

November 22, 2020

Last Updated

February 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

On completion of study, investigators are open to participation in planned IPD projects with a prospective registration, subject to appropriate approvals

Locations

PA(11)