NCT04447534

Brief Summary

we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine in treatment of COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
191

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_3

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

First Submitted

Initial submission to the registry

June 23, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

22 days

First QC Date

June 23, 2020

Last Update Submit

March 23, 2022

Conditions

COVID

Outcome Measures

Primary Outcomes (1)

  • Number of patients with improvement or mortality

    The number of patients with improvement or mortality.

    2 weeks

Study Arms (2)

Chloroquine or hydroxychloroquine

EXPERIMENTAL

Chloroquine or hydroxychloroquine alone

Drug: Chloroquine or hydroxychloroquine

Chloroquine or hydroxychloroquine with zinc

EXPERIMENTAL

Chloroquine or hydroxychloroquine with zinc

Drug: Chloroquine or hydroxychloroquineDrug: zinc

Interventions

Chloroquine or hydroxychloroquineDRUG

Chloroquine or hydroxychloroquine

Also known as: alexoquine, chloroquine, hydroquine
Chloroquine or hydroxychloroquineChloroquine or hydroxychloroquine with zinc
zincDRUG

Zinc tablets

Chloroquine or hydroxychloroquine with zinc

Eligibility Criteria

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

You may qualify if:

  • Patients with positive COVID-19.

You may not qualify if:

  • Contraindications or hypersensitivity to chloroquine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university hospital, Assuit University, Ainshams University

Tanta, Egypt

Location

Related Publications (1)

  • Abd-Elsalam S, Soliman S, Esmail ES, Khalaf M, Mostafa EF, Medhat MA, Ahmed OA, El Ghafar MSA, Alboraie M, Hassany SM. Do Zinc Supplements Enhance the Clinical Efficacy of Hydroxychloroquine?: a Randomized, Multicenter Trial. Biol Trace Elem Res. 2021 Oct;199(10):3642-3646. doi: 10.1007/s12011-020-02512-1. Epub 2020 Nov 27.

    PMID: 33247380DERIVED

MeSH Terms

Interventions

ChloroquineHydroxychloroquineZinc

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • sherief Abd-Elsalam, Ass. Prof.

    ass. Prof. Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

June 23, 2020

First Posted

June 25, 2020

Study Start

June 23, 2020

Primary Completion

July 15, 2020

Study Completion

August 15, 2020

Last Updated

April 1, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)