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

Covid-19 Infection Prophylaxis With Low Dose of Doxycycline and Zinc in Health Care Workers

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: Doxycyclin

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Phase 3

Contacts and Locations

Study Locations

• Tunisia
  • Montfleury
    • Tunis, Montfleury, Tunisia, 1008
      • Military Hospital of Tunis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DOXY ZINC; Doxycycline daily dosing (100mg) Zinc daily dosing (15mg)	Drug: Doxycyclin; daily (100mg)
Placebo Comparator: DOXY PLACEBO; Doxycycline daily dosing (100mg) placebo of Zinc	Drug: Doxycyclin; daily (100mg)
Placebo Comparator: PLACEBO; placebo of Doxycycline daily dosing placebo of Zinc	Drug: Doxycyclin; daily (100mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decreasing the number of cases infected with covid 19	Determine if the use of doxyciciline low dose as preventive treatment decrease the number of cases infected with covid 19 in the active arm compared to the placebo arm. Participants for each randomized treatment arm as compared to placebo.	WEEK 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the emergence of clincal symptoms of COVID 19	Comparison of the emergence of clinical symptoms or COVID-19 diagnosis in participants presenting asymptomatically at study entry but identified as seropositive by serology at entry between the randomized treatment arms and comparator arm.	WEEK 6
the seroprevalence of SARS- CoV 2 IgM/IgG positive samples at study entry and study conclusion in all participants receiving DOXY compared to those receiving placebo.	Comparison of the rate of SARS-CoV 2 infections as measured by IgM/IgG seroconversion in study participants receiving randomized DOXY versus placebo.	WEEK 6

Collaborators and Investigators

• Sponsor: Hedi Gharsallah
• Collaborators: Dacima Consulting
• Investigators: Study Chair: Batikh R Riadh, physican, Military Hospital; Study Director: Stambouli N nejla, phd, Military Hospital; Principal Investigator: Gharsallah H Hedi, physican, Military Hospital; Study Chair: Ferjani M Mustapha, physican, Direction de la Santé militaire; Study Chair: Ben Moussa M mohamed, physican, Military Hospital; Study Chair: Youssfi MA Mohamed Al, physican, Military Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: UR17DN05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No