NCT04394442

Brief Summary

Many reports argued about the possible beneficial effects of Hydroxychloroquine in treating COVID-19 patients and this study was designed to investigate this claim

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for phase_2 covid19

Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 21, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

May 17, 2020

Last Update Submit

May 18, 2020

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

  • time to viral clearance

    PCR will be done every 72 h day till 2 consecutive negative PCR tests(24h apart) which is the viral clearance.The time between randomization and viral clearance is the viral clearance time

    21 days after patients randomization

  • % of mortality

    total number of deaths divided by total number of the group

    60 days after randomization

Secondary Outcomes (3)

  • Length of stay

    60 days after randomization

  • time to be afebrile

    60 days after randomization

  • need for mechanical ventilation

    60 days after randomization

Study Arms (2)

Hydroxycholoroquine group

EXPERIMENTAL
Drug: Hydroxychloroquine

Control group

NO INTERVENTION

Interventions

HydroxychloroquineDRUG

400mg BD first day then 200 mg BD for 5 days

Hydroxycholoroquine group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed cases of SARS-CoV-2 by PCR

You may not qualify if:

  • less than 18 years old known hypersensitivity to the drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNH

Mecca, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

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 Compounds

Central Study Contacts

Samah M Lutfy, MD

CONTACT

+966581244415omar1star2008@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor of chest diseases

Study Record Dates

First Submitted

May 17, 2020

First Posted

May 19, 2020

Study Start

March 21, 2020

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

May 19, 2020

Record last verified: 2020-05

Locations

SA(1)