COVIDPhase 3NCT04447534
Zinc With Chloroquine/Hydroxychloroquine in Treatment of COVID-19
A Phase 3 study testing Chloroquine or hydroxychloroquine and zinc in people with COVID, run by Tanta University at 1 site in Egypt.
Trial summary
we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine in treatment of COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID
- What is being tested?
- Chloroquine or hydroxychloroquine and zinc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jun 2020to 15 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with positive COVID-19.
Who cannot join
- Contraindications or hypersensitivity to chloroquine.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Tanta university hospital, Assuit University, Ainshams University
Tanta
About this study
Official title: Does Zinc Supplementation Enhance the Clinical Efficacy of Chloroquine/Hydroxychloroquine in Treatment of COVID-19?
we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine in treatment of COVID-19.
Read the detailed description
we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine in treatment of COVID-19. As, zinc may be of value in these cases and may be of value in enhancing chloroquine effect.
- Conditions
- COVID
- Being tested
- Chloroquine or hydroxychloroquine, zinc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chloroquine or hydroxychloroquineDrug
Also called alexoquine, chloroquine, hydroquine
Chloroquine or hydroxychloroquine
zincDrug
Zinc tablets
| Study group | Role | What they receive |
|---|---|---|
| Chloroquine or hydroxychloroquine | Experimental | Chloroquine or hydroxychloroquine alone Receives: Drug: Chloroquine or hydroxychloroquine |
| Chloroquine or hydroxychloroquine with zinc | Experimental | Chloroquine or hydroxychloroquine with zinc Receives: Drug: Chloroquine or hydroxychloroquine; Drug: zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with improvement or mortality
The number of patients with improvement or mortality.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start23 Jun 2020
- Primary completion15 Jul 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- sherief Abd-Elsalam, Ass. Prof., Principal investigator, ass. Prof. Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447534
- Sponsor's protocol ID
- tanta zinc chloroquine
- Status last verified
- Mar 2022
- First submitted
- 23 Jun 2020
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abd-Elsalam S, Soliman S, Esmail ES, Khalaf M, Mostafa EF, Medhat MA, Ahmed OA, El Ghafar MSA, Alboraie M, Hassany SM. Do Zinc Supplements Enhance the Clinical Efficacy of Hydroxychloroquine?: a Randomized, Multicenter Trial. Biol Trace Elem Res. 2021 Oct;199(10):3642-3646. doi: 10.1007/s12011-020-02512-1. Epub 2020 Nov 27.
PubMed 33247380
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Zinc Supplementation Enhance the Clinical Efficacy of Chloroquine/Hydroxychloroquine in Treatment of COVID-19?
- ClinicalTrials.gov ID
- NCT04447534
- Acronym / sponsor ID
- tanta zinc chloroquine
- Conditions
- COVID
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 25 Jun 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.
we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine in treatment of COVID-19.
Detailed description
we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine in treatment of COVID-19. As, zinc may be of value in these cases and may be of value in enhancing chloroquine effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chloroquine or hydroxychloroquine | Experimental | Drug: Chloroquine or hydroxychloroquineChloroquine or hydroxychloroquine alone |
| Chloroquine or hydroxychloroquine with zinc | Experimental | Drug: Chloroquine or hydroxychloroquine, Drug: zincChloroquine or hydroxychloroquine with zinc |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with positive COVID-19.
Key exclusion criteria (1 listed)
- Contraindications or hypersensitivity to chloroquine.
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 |
|---|---|---|
| Chloroquine or hydroxychloroquineAlso: alexoquine, chloroquine, hydroquineChloroquine or hydroxychloroquine | Drug | Chloroquine or hydroxychloroquine, Chloroquine or hydroxychloroquine with zinc |
| zincZinc tablets | Drug | Chloroquine or hydroxychloroquine with zinc |
Primary outcome
Number of patients with improvement or mortality
Time frame: 2 weeks
The number of patients with improvement or mortality.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Derived from this study: PubMed 33247380Abd-Elsalam S, Soliman S, Esmail ES, Khalaf M, Mostafa EF, Medhat MA, Ahmed OA, El Ghafar MSA, Alboraie M, Hassany SM. Do Zinc Supplements Enhance the Clinical Efficacy of Hydroxychloroquine?: a Randomized, Multicenter Trial. Biol Trace Elem Res. 2021 Oct;199(10):3642-3646. doi: 10.1007/s12011-020-02512-1. Epub 2020 Nov 27.
- Individual participant dataSharing planned: No
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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.
sherief Abd-Elsalam, Ass. Prof. principal investigator
ass. Prof. Tropical Medicine
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 Chloroquine or hydroxychloroquine and zinc in people with COVID, run by Tanta University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Apr 2022. 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 Egypt. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with improvement or mortality (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04447534, which also lists 1 linked publication.
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 1 Apr 2022.