COVIDPhase 2/3NCT04345419
Remdesivir Efficacy in Coronavirus Disease
A Phase 2/3 study testing Remdesivir in people with COVID, run by Tanta University at 1 site in Egypt.
Trial summary
COVID 19 treatment using Remedesvir. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID
- What is being tested?
- Remdesivir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jun 2020to 1 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- COVID 19 patients
Who cannot join
- allergy or contraindication to the drug
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Tanta university hospital, Assuit University, Ainshams University
Tanta
About this study
Official title: Remdesivir in COVID-19 Treatment: A Randomised Trial
COVID 19 treatment using Remedesvir.
Read the detailed description
COVID 19 treatment using Remedesvir. Is this drug effective?
- Conditions
- COVID
- Being tested
- Remdesivir, Standard of care treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemdesivirDrug
Remdesivir as antiviral drug
Standard of care treatmentOther
Standard of care treatment
| Study group | Role | What they receive |
|---|---|---|
| Remdesivir | Experimental | Remdesivir with standard of care treatment standard of care treatment Receives: Drug: Remdesivir; Other: Standard of care treatment |
| Standard of care | Placebo comparator | Standard of care treatment alone. Receives: Other: Standard of care treatment |
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 estimated number of patients with improvement or mortality
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 posted14 Apr 2020
- Study start16 Jun 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 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
- NCT04345419
- Sponsor's protocol ID
- COVID 19 treatment
- Status last verified
- Jul 2021
- First submitted
- 11 Apr 2020
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.
PubMed 36695483
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remdesivir in COVID-19 Treatment: A Randomised Trial
- ClinicalTrials.gov ID
- NCT04345419
- Acronym / sponsor ID
- COVID 19 treatment
- Conditions
- COVID
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 14 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.
COVID 19 treatment using Remedesvir.
Detailed description
COVID 19 treatment using Remedesvir. Is this drug effective?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remdesivir | Experimental | Drug: Remdesivir, Other: Standard of care treatmentRemdesivir with standard of care treatment standard of care treatment |
| Standard of care | Placebo comparator | Other: Standard of care treatmentStandard of care treatment alone. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- COVID 19 patients
Key exclusion criteria (1 listed)
- allergy or contraindication to the drug
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 |
|---|---|---|
| RemdesivirRemdesivir as antiviral drug | Drug | Remdesivir |
| Standard of care treatmentStandard of care treatment | Other | Remdesivir, Standard of care |
Primary outcome
Number of patients with improvement or mortality
Time frame: 6 months
the estimated 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 2 Aug 2021.
- Derived from this study: PubMed 36695483Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.
- 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 Remdesivir 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 2 Aug 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. 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 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 improvement or mortality (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 NCT04345419, 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 2 Aug 2021.