Sars-CoV2Phase 3COVID-MilitNCT04377646
A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers
A Phase 3 study testing Hydroxychloroquine and Zinc in people with Sars-CoV2 and COVID19, run by Military Hospital of Tunis at 1 site in Tunisia.
Trial summary
A multicenter randomized clinical trial aiming to assess the efficacy of hydroxychloroquine associated to Zinc compared to hydroxychloroquine, in the prevention of Military Health Professionals Exposed to SARS CoV2 in Tunisia Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Hydroxychloroquine and Zinc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 660 participants
- Where
- 1 siteTunisia
- Study dates
- 4 May 2020to 31 Jul 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No self-medication with chloroquine, hydroxychloroquine or antivirals
- COVID-19 negative diagnosis confirmed by "rapid test" and "PCR test" (Polymerase Chain Reaction test)
- No clinical symptoms suggestive of COVID-19
- Having given written consent for their participation in the study
Who cannot join
- Participation in other clinical trials for the treatment or prevention of SARS-COV-2 infection within 30 days before inclusion
- Hypersensitivity to any of the drugs or to any of its excipients.
- ECG showing rhythm disturbances, QT interval> 500 ms, conduction disturbances.
- Severe hepatic impairment.
- Concomitant treatments : colchicin, ergot of rye, pimozide, mizolastin, simvastatin, lomitapide, alfuzosin, dapoxetin, avanafil, ivabradin, eplerenone, dronedaron, quetiapine, ticagrelor, cisapride, astemizole, astemizol.
- Retinal pathology.
Show all 13Show fewer
- Epilepsy.
- Myasthenia.
- Psoriasis.
- Methemoglobinemia.
- Porphyria.
- Pregnant or lactating women
- Contraindication to the study products
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Military Hospital of Tunis
Tunis
Faida Ajili, MD, +21698631188, faida1977@yahoo.fr
Nejla Stambouli, PhD, +21655104234, nejlastam@gmail.com
About this study
Official title: A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers (COVID-Milit)
A multicenter randomized clinical trial aiming to assess the efficacy of hydroxychloroquine associated to Zinc compared to hydroxychloroquine, in the prevention of Military Health Professionals Exposed to SARS CoV2 in Tunisia
Read the detailed description
Detailed Description: The study is a multicenter randomized controlled double blind clinical trial, including up to 660 military health professionals working in Tunisia and exposed to SARS CoV2 at different levels (2 levels of exposure).
The trial will assess the efficacy of hydroxychloroquine associated to Zinc compared to hydrxyochloroquine. Randomization will be performed by IWRS (Interactive Web Response System) by random double blocs of 9 and 6.
Collected data are managed by the electronic data capture system (DACIMA Clinical Suite),according to the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the EU GDPR (European General Data Protection Regulation), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation)
- Being tested
- Hydroxychloroquine, Hydroxychloroquine (placebo), Zinc, Zinc (Placebo)
- Keywords
- Prophylaxis, Zinc, Hydroxychloroquine, Health Professionals, Military
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400 mg at day 1 and day 2, then 400 mg weekly up to 2 months
Hydroxychloroquine (placebo)Drug
1 pill at day 1 and day 2, then 1 pill weekly up to 2 months
ZincDrug
15 mg per day up to 2 months
Zinc (Placebo)Drug
1 pill per day up to 2 months
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine & Zinc | Active comparator | Will receive:
* Hydroxychloroquine 400 mg at day 1 and day 2, then a weekly dose of 400 mg up to 2 months.
* Zinc 15 mg at daily dose up to 2 months Receives: Drug: Hydroxychloroquine; Drug: Zinc |
| Hydroxychloroquine | Active comparator | Will receive:
* Hydroxychloroquine 400 mg at day 1 and day 2, then a weekly dose of 400 mg up to 2 months.
* Placebo of Zinc Receives: Drug: Hydroxychloroquine; Drug: Zinc (Placebo) |
| Placebo | Placebo comparator | Will receive a double placebo (Hydroxychloroquine and Zinc) up to 2 months Receives: Drug: Hydroxychloroquine (placebo); Drug: Zinc (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS CoV2 infection
Frequency of confirmed SARS CoV2 infection
Measured: At 2 months of follow-up
Secondary outcomes (2)
COVID-19 symptoms description
Any COVID-19 related symptoms (cough, fever, headache, vomiting, nausea, dyspnea, diarrhea, smell disorder,conjunctivitis, dizziness)
Measured: At 2 months of follow-up
Adverse Events
Any adverse event or serious adverse event
Measured: each month up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start4 May 2020 (estimated)
- Primary completion24 May 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized clinical trial with 3 arms
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Hospital of Tunis
- Sponsor type
- University, hospital or other
- Collaborators
- UR17DN02 : Autoimmune Diseases Research Unit, Dacima Consulting
- Responsible party
- Sponsor
- Investigators
- Faida Ajili, MD, Study chair, Military Hospital of TunisNejla Mrabet, PhD, Study director, Military Hospital of Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377646
- Sponsor's protocol ID
- UR17DN02-001
- Other IDs
- TN2020-NAT-INS-38
- Acronym
- COVID-Milit
- Status last verified
- May 2020
- First submitted
- 1 May 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers (COVID-Milit)
- ClinicalTrials.gov ID
- NCT04377646
- Acronym / sponsor ID
- COVID-Milit / UR17DN02-001
- Keywords
- Prophylaxis, Zinc, Hydroxychloroquine, Health Professionals, Military
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Military Hospital of TunisUniversity, hospital or other
- Collaborators
- UR17DN02 : Autoimmune Diseases Research Unit, Dacima Consulting
- Study start
- 4 May 2020 (estimated)
- Primary completion
- 24 May 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter randomized clinical trial aiming to assess the efficacy of hydroxychloroquine associated to Zinc compared to hydroxychloroquine, in the prevention of Military Health Professionals Exposed to SARS CoV2 in Tunisia
Detailed description
Detailed Description: The study is a multicenter randomized controlled double blind clinical trial, including up to 660 military health professionals working in Tunisia and exposed to SARS CoV2 at different levels (2 levels of exposure).
The trial will assess the efficacy of hydroxychloroquine associated to Zinc compared to hydrxyochloroquine. Randomization will be performed by IWRS (Interactive Web Response System) by random double blocs of 9 and 6.
Collected data are managed by the electronic data capture system (DACIMA Clinical Suite),according to the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the EU GDPR (European General Data Protection Regulation), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Double blind randomized clinical trial with 3 arms
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine & Zinc | Active comparator | Drug: Hydroxychloroquine, Drug: ZincWill receive: * Hydroxychloroquine 400 mg at day 1 and day 2, then a weekly dose of 400 mg up to 2 months. * Zinc 15 mg at daily dose up to 2 months |
| Hydroxychloroquine | Active comparator | Drug: Hydroxychloroquine, Drug: Zinc (Placebo)Will receive: * Hydroxychloroquine 400 mg at day 1 and day 2, then a weekly dose of 400 mg up to 2 months. * Placebo of Zinc |
| Placebo | Placebo comparator | Drug: Hydroxychloroquine (placebo), Drug: Zinc (Placebo)Will receive a double placebo (Hydroxychloroquine and Zinc) up to 2 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No self-medication with chloroquine, hydroxychloroquine or antivirals
- COVID-19 negative diagnosis confirmed by "rapid test" and "PCR test" (Polymerase Chain Reaction test)
- No clinical symptoms suggestive of COVID-19
- Having given written consent for their participation in the study
Key exclusion criteria (13 listed)
- Participation in other clinical trials for the treatment or prevention of SARS-COV-2 infection within 30 days before inclusion
- Hypersensitivity to any of the drugs or to any of its excipients.
- ECG showing rhythm disturbances, QT interval> 500 ms, conduction disturbances.
- Severe hepatic impairment.
- Concomitant treatments : colchicin, ergot of rye, pimozide, mizolastin, simvastatin, lomitapide, alfuzosin, dapoxetin, avanafil, ivabradin, eplerenone, dronedaron, quetiapine, ticagrelor, cisapride, astemizole, astemizol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine400 mg at day 1 and day 2, then 400 mg weekly up to 2 months | Drug | Hydroxychloroquine, Hydroxychloroquine & Zinc |
| Hydroxychloroquine (placebo)1 pill at day 1 and day 2, then 1 pill weekly up to 2 months | Drug | Placebo |
| Zinc15 mg per day up to 2 months | Drug | Hydroxychloroquine & Zinc |
| Zinc (Placebo)1 pill per day up to 2 months | Drug | Hydroxychloroquine, Placebo |
Primary outcome
SARS CoV2 infection
Time frame: At 2 months of follow-up
Frequency of confirmed SARS CoV2 infection
2 secondary outcomes
COVID-19 symptoms description
Time frame: At 2 months of follow-up
Adverse Events
Time frame: each month up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Individual participant dataSharing planned: No
Related trials for Sars-CoV2
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faida Ajili, MD study chair
Military Hospital of Tunis
Nejla Mrabet, PhD study director
Military Hospital of Tunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine and Zinc in people with Sars-CoV2 and COVID19, run by Military Hospital of Tunis at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faida Ajili, MD (+21698631188, faida1977@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS CoV2 infection (time frame: At 2 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.