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

Sponsor
Hedi Gharsallah (Other)
Overall Status
Completed
CT.gov ID
NCT04584567
Collaborator
Dacima Consulting (Other)
194
Enrollment
1
Location
3
Arms
11.4
Actual Duration (Months)
17.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
194 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Double (Participant, Investigator)
Masking Description:
Double
Primary Purpose:
Prevention
Official Title:
Covid-19 Infection Prophylaxis With Low Dose of Doxycycline and Zinc in Health Care Workers
Actual Study Start Date :
Nov 20, 2020
Actual Primary Completion Date :
Feb 1, 2021
Actual Study Completion Date :
Nov 1, 2021

Arms and Interventions

ArmIntervention/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)

Outcome Measures

Primary Outcome Measures

  1. decreasing the number of cases infected with covid 19 [WEEK 6]

    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.

Secondary Outcome Measures

  1. Measurement of the emergence of clincal symptoms of COVID 19 [WEEK 6]

    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.

  2. 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. [WEEK 6]

    Comparison of the rate of SARS-CoV 2 infections as measured by IgM/IgG seroconversion in study participants receiving randomized DOXY versus placebo.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Military Hospital of TunisTunisMontfleuryTunisia1008

Sponsors and Collaborators

  • Hedi Gharsallah
  • 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 Sant√© militaire
  • Study Chair: Ben Moussa M mohamed, physican, Military hospital
  • Study Chair: Youssfi MA Mohamed Al, physican, Military hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hedi Gharsallah, Professor, General Administration of Military Health, Tunisia
ClinicalTrials.gov Identifier:
NCT04584567
Other Study ID Numbers:
  • UR17DN05
First Posted:
Oct 14, 2020
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021