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OD-doxy-PNV-COVID-19 Old Drug " DOXY " for Prevention of New Virus " COVID-19 "

NCT ID: NCT04584567

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-20

Study Completion Date

2021-11-01

Brief Summary

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Given the urgency of having guidelines for the management of COVID-19 in the current epidemic context and the lack of specific pharmacological treatment, Military Health recommends the launch of a multicenter, randomized, double-blind, interventional clinical trial.

The aim of this study is to evaluate the efficacy of a combination of two treatments, low-dose doxcycline (100 mg/day) and Zinc (15 mg/day) (dietary supplement) in the primary prevention of COVID-19 infection in health care professionals in Tunisia compared to two control groups.

Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The participants who meeting study entry criteria will be randomized in a 1:1 blinded comparison of daily low dose DOXY versus oral placebo for 6 weeks.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Double

Study Groups

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DOXY ZINC

Doxycycline daily dosing (100mg) Zinc daily dosing (15mg)

Group Type EXPERIMENTAL

Doxycyclin

Intervention Type DRUG

daily (100mg)

DOXY PLACEBO

Doxycycline daily dosing (100mg) placebo of Zinc

Group Type PLACEBO_COMPARATOR

Doxycyclin

Intervention Type DRUG

daily (100mg)

PLACEBO

placebo of Doxycycline daily dosing placebo of Zinc

Group Type PLACEBO_COMPARATOR

Doxycyclin

Intervention Type DRUG

daily (100mg)

Interventions

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Doxycyclin

daily (100mg)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* No self-medication with study drugs or antivirals
* Negative COVID19 diagnosis confirmed by PCR and negative Elisa antibody assay
* No signs of COVID19
* Having given consent for the study

Exclusion Criteria

Participation in other clinical trials aimed at primary prevention of VIDOC infection19

* Liver failure
* Known allergy to the study product
* Pregnancy or breastfeeding
* Vitamin A and E treatment in progress
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dacima Consulting

OTHER

Sponsor Role collaborator

Hedi Gharsallah

NETWORK

Sponsor Role lead

Responsible Party

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Hedi Gharsallah

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Batikh R Riadh, physican

Role: STUDY_CHAIR

Military hospital

Stambouli N nejla, phd

Role: STUDY_DIRECTOR

Military hospital

Gharsallah H Hedi, physican

Role: PRINCIPAL_INVESTIGATOR

Military hospital

Ferjani M Mustapha, physican

Role: STUDY_CHAIR

Direction de la Santé militaire

Ben Moussa M mohamed, physican

Role: STUDY_CHAIR

Military hospital

Youssfi MA Mohamed Al, physican

Role: STUDY_CHAIR

Military hospital

Locations

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Military Hospital of Tunis

Tunis, Montfleury, Tunisia

Site Status

Countries

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Tunisia

Other Identifiers

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UR17DN05

Identifier Type: -

Identifier Source: org_study_id