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Status unknownNCT04394442Updated May 19, 2020

Hydroxychloroquine in COVID-19 Patients

A Phase 2 interventional study of Hydroxychloroquine in COVID-19, sponsored by Samah Lutfy. Status unknown at 1 site in Saudi Arabia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-05-19.

Sponsored by Samah Lutfy · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

  • COVID-19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

This is the only study on the registry with Samah Lutfy as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Confirmed cases of SARS-CoV-2 by PCR

Exclusion criteria

Exclusion Criteria:

less than 18 years old known hypersensitivity to the drug

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Hydroxycholoroquine group

    Drug: Hydroxychloroquine

  • No intervention
    Control group

Interventions

  • DrugHydroxychloroquine

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 21 days after patients randomization

  2. % of mortality

    total number of deaths divided by total number of the group

    Time frame: 60 days after randomization

Secondary outcomes

  1. Length of stay

    time from patients randomization till discharge

    Time frame: 60 days after randomization

  2. time to be afebrile

    time from randomization till day of fever subsiding

    Time frame: 60 days after randomization

  3. need for mechanical ventilation

    %of deteriorated patients necessitates mechanical ventilation

    Time frame: 60 days after randomization

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04394442
Lead sponsor
Samah Lutfy
Responsible party
Samah Lutfy (Assistant professor of chest diseases, Zagazig University) — Sponsor-investigator
First posted
May 19, 2020
Start date
Mar 21, 2020
Primary completion
Aug 2020 (estimated)
Completion
Aug 2020 (estimated)
Last update
May 19, 2020

Study contacts

Samah M Lutfy, MD
Contact
omar1star2008@yahoo.com
+966581244415

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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