COVIDPhase 2/3NCT04351295
Efficacy of Faviprevir in COVID-19 Treatment
A Phase 2/3 study testing Favipiravir and Chloroquine in people with COVID, run by Tanta University at 1 site in Egypt.
Trial summary
Faviprevir in COVID-19 treatment Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID
- What is being tested?
- Favipiravir and Chloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2020to 28 Sep 2020
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with covid 19
Who cannot join
- Allergy or contraindications to faviprevir
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study Evaluating the Efficacy of Faviprevir in COVID-19 Treatment
Faviprevir in COVID-19 treatment
Read the detailed description
Clinical Study Evaluating the Efficacy of Faviprevir in COVID-19 treatment
- Conditions
- COVID
- Being tested
- Favipiravir, Chloroquine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FavipiravirDrug
Also called Faviprevir
Favipiravir
ChloroquineDrug
chloroquine oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Faviprevir | Experimental | Faviprevir Receives: Drug: Favipiravir |
| chloroquine | Active comparator | chloroquine Receives: Drug: Chloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with mortality or need for mechanical ventilation
Number of patients with mortality or need for mechanical ventilation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start20 Apr 2020
- Primary completion28 Sep 2020
- Study completion28 Sep 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 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, Tanta University - Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351295
- Sponsor's protocol ID
- faviprevir covid
- Status last verified
- Oct 2021
- First submitted
- 15 Apr 2020
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dabbous HM, Abd-Elsalam S, El-Sayed MH, Sherief AF, Ebeid FFS, El Ghafar MSA, Soliman S, Elbahnasawy M, Badawi R, Tageldin MA. Efficacy of favipiravir in COVID-19 treatment: a multi-center randomized study. Arch Virol. 2021 Mar;166(3):949-954. doi: 10.1007/s00705-021-04956-9. Epub 2021 Jan 25.
PubMed 33492523
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Efficacy of Faviprevir in COVID-19 Treatment
- ClinicalTrials.gov ID
- NCT04351295
- Acronym / sponsor ID
- faviprevir covid
- Conditions
- COVID
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 17 Apr 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.
Faviprevir in COVID-19 treatment
Detailed description
Clinical Study Evaluating the Efficacy of Faviprevir in COVID-19 treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Faviprevir | Experimental | Drug: FavipiravirFaviprevir |
| chloroquine | Active comparator | Drug: Chloroquinechloroquine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with covid 19
Key exclusion criteria (1 listed)
- Allergy or contraindications to faviprevir
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 |
|---|---|---|
| FavipiravirAlso: FaviprevirFavipiravir | Drug | Faviprevir |
| Chloroquinechloroquine oral tablets | Drug | chloroquine |
Primary outcome
Number of patients with mortality or need for mechanical ventilation
Time frame: 6 months
Number of patients with mortality or need for mechanical ventilation
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 Nov 2021.
- Derived from this study: PubMed 33492523Dabbous HM, Abd-Elsalam S, El-Sayed MH, Sherief AF, Ebeid FFS, El Ghafar MSA, Soliman S, Elbahnasawy M, Badawi R, Tageldin MA. Efficacy of favipiravir in COVID-19 treatment: a multi-center randomized study. Arch Virol. 2021 Mar;166(3):949-954. doi: 10.1007/s00705-021-04956-9. Epub 2021 Jan 25.
- 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
Tanta University - Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Favipiravir and Chloroquine 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 Nov 2021. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 mortality or need for mechanical ventilation (time frame: 6 months). 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 NCT04351295, 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 Nov 2021.