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OpenTrials
Completed

NCT Number: NCT04584567

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Military Hospital of Tunis

Tunis, Montfleury, 1008, Tunisia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxycyclin

Drug

daily (100mg)

Primary outcomes

  1. decreasing the number of cases infected with covid 19

    Time frame: 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 outcomes

  1. Measurement of the emergence of clincal symptoms of COVID 19

    Time frame: 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hedi Gharsallah

Network

Collaborators

  • Dacima Consulting

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2020
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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