NCT04353336

Brief Summary

Chloroquine or hydroxychloroquine in COVID-19 treatment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
194

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
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

Study Start

First participant enrolled

March 23, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

April 15, 2020

Last Update Submit

July 29, 2021

Conditions

COVID-19Coronavirus Infection

Outcome Measures

Primary Outcomes (1)

  • Number of patients with cure or death

    the number of patients with cure or death

    1 month

Study Arms (2)

Chloroquine or Hydroxychloroquine

EXPERIMENTAL

Chloroquine or Hydroxychloroquine with standard of care treatment.

Drug: Chloroquine or Hydroxychloroquine

No intervention

NO INTERVENTION

standard of care treatment alone.

Interventions

Chloroquine or HydroxychloroquineDRUG

Chloroquine or Hydroxychloroquine

Also known as: alexoquine, chloroquine, Hydroquine
Chloroquine or Hydroxychloroquine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Covid 19 patients

You may not qualify if:

  • Allergy or contraindication to the drug
  • Pregnant or lactating
  • Patients with cardiac problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University, Assiut University

Tanta, 35111, Egypt

Location

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

ChloroquineHydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • sherief Abd-Elsalam, Ass. Prof.

    Tanta University - Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 20, 2020

Study Start

March 23, 2020

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

August 2, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)