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

Primary Purpose

Covid19

Status

Completed

Phase

Phase 3

Locations

Tunisia

Study Type

Interventional

Intervention

Doxycyclin

About this trial

This is an interventional prevention trial for Covid19

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Military Hospital of Tunis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

DOXY ZINC

DOXY PLACEBO

PLACEBO

Arm Description

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

Doxycycline daily dosing (100mg) placebo of Zinc

placebo of Doxycycline daily dosing placebo of Zinc

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT04584567

First Posted

October 6, 2020

Last Updated

November 18, 2021

Sponsor

Hedi Gharsallah

Collaborators

Dacima Consulting

1. Study Identification

Unique Protocol Identification Number

NCT04584567

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

November 20, 2020 (Actual)

Primary Completion Date

February 1, 2021 (Actual)

Study Completion Date

November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hedi Gharsallah

Collaborators

Dacima Consulting

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantInvestigator

Masking Description

Double

Allocation

Randomized

Enrollment

194 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DOXY ZINC

Arm Type

Experimental

Arm Description

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

Arm Title

DOXY PLACEBO

Arm Type

Placebo Comparator

Arm Description

Doxycycline daily dosing (100mg) placebo of Zinc

Arm Title

PLACEBO

Arm Type

Placebo Comparator

Arm Description

placebo of Doxycycline daily dosing placebo of Zinc

Intervention Type

Drug

Intervention Name(s)

Doxycyclin

Intervention Description

daily (100mg)

Primary Outcome Measure Information:

Title

decreasing the number of cases infected with covid 19

Description

Time Frame

WEEK 6

Secondary Outcome Measure Information:

Title

Measurement of the emergence of clincal symptoms of COVID 19

Description

Time Frame

WEEK 6

Title

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.

Description

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

Time Frame

WEEK 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: