Covid19Phase 3NCT04853901
Remdesivir Efficacy In Management Of COVID-19 Patients
A Phase 3 study testing Remdesivir in people with Covid19, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study is open label randomized interventional phase 3 clinical trial. Patients with confirmed Covid-19 cases who was hospitalized in Two university isolation hospitals (Ain Shams University and Assiut University ) assigned hospitals for isolation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- Remdesivir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Jul 2020to 1 Mar 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 18 -80 years old Must have laboratory confirmed COVID-19(A patient with laboratory confirmation (Positive RT-PCR) of COVID-19 infection, irrespective of clinical signs and symptoms according to Ain Shams University Hospitals Consensus Statement on Management of Adult COVID-19 Patients.
- Must have severe or immediately life-threatening COVID-19,
- Severe disease is defined as:
- Dyspnea,
- Respiratory frequency ≥ 30/min,
- Blood oxygen saturation ≤ 93%,
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- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours
- Life-threatening disease is defined as:
- respiratory failure,
- septic shock, and/or
- multiple organ dysfunction or failure
- Must provide informed consent by patient or his/her legal guardian or Professional Legal Representative
Who cannot join
- Mild to moderately affected COVID 19 confirmed patients.
- pregnancy, lactation.
- known hepatic failure.
- Patient who is not likely to comply to study procedures.
- Creatine clearance <30 ml/min.
- Elevated transaminases > 5 fold ULN.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, 11566
About this study
The study is open label randomized interventional phase 3 clinical trial. Patients with confirmed Covid-19 cases who was hospitalized in Two university isolation hospitals (Ain Shams University and Assiut University ) assigned hospitals for isolation.
Read the detailed description
The study is open label randomized interventional phase 3 clinical trial. Patients with confirmed Covid-19 cases who was hospitalized in Two university isolation hospitals (Ain Shams University and Assiut University ) assigned hospitals for isolation.
The included patients receive. Intervention group: Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days + Methylprednisolone 1-2mg/kg for 5-7 days Control group: standard of care without Remdesivir
- Conditions
- Covid19
- Being tested
- Remdesivir, Standard of care_1, Standard of care_2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemdesivirDrug
Also called Veklury
Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days
Standard of care_1Drug
Also called Plaquenil
Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days
Standard of care_2Drug
Also called Steroid
Methylprednisolone 1-2mg/kg for 5-7 days
| Study group | Role | What they receive |
|---|---|---|
| Remdesivir | Experimental | Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days + Methylprednisolone 1-2mg/kg for 5-7 days Receives: Drug: Remdesivir |
| Standard of care therapy | Active comparator | Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days + Methylprednisolone 1-2mg/kg for 5-7 days Receives: Drug: Standard of care_1; Drug: Standard of care_2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of viral clearance
Achievement of two successive negative COVID-19 PCR analysis tests 72 hours apart
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start27 Jul 2020
- Primary completion1 Jan 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Ain Shams 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
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Dabbous, Ain Shams University
- Investigators
- Hany E Dabbous, M.D, Principal investigator, Faculty of Medicine Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853901
- Sponsor's protocol ID
- FMASU P56a/ 2020
- Status last verified
- Apr 2021
- First submitted
- 1 Mar 2021
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remdesivir Efficacy In Management Of COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04853901
- Acronym / sponsor ID
- FMASU P56a/ 2020
- Conditions
- Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 22 Apr 2021 (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.
The study is open label randomized interventional phase 3 clinical trial. Patients with confirmed Covid-19 cases who was hospitalized in Two university isolation hospitals (Ain Shams University and Assiut University ) assigned hospitals for isolation.
Detailed description
The study is open label randomized interventional phase 3 clinical trial. Patients with confirmed Covid-19 cases who was hospitalized in Two university isolation hospitals (Ain Shams University and Assiut University ) assigned hospitals for isolation.
The included patients receive. Intervention group: Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days + Methylprednisolone 1-2mg/kg for 5-7 days Control group: standard of care without Remdesivir
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remdesivir | Experimental | Drug: RemdesivirRemdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days + Methylprednisolone 1-2mg/kg for 5-7 days |
| Standard of care therapy | Active comparator | Drug: Standard of care_1, Drug: Standard of care_2Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days + Methylprednisolone 1-2mg/kg for 5-7 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult 18 -80 years old Must have laboratory confirmed COVID-19(A patient with laboratory confirmation (Positive RT-PCR) of COVID-19 infection, irrespective of clinical signs and symptoms according to Ain Shams University Hospitals Consensus Statement on Management of Adult COVID-19 Patients.
- Must have severe or immediately life-threatening COVID-19,
- Severe disease is defined as:
- Life-threatening disease is defined as:
- Must provide informed consent by patient or his/her legal guardian or Professional Legal Representative
Key exclusion criteria (6 listed)
- Mild to moderately affected COVID 19 confirmed patients.
- pregnancy, lactation.
- known hepatic failure.
- Patient who is not likely to comply to study procedures.
- Creatine clearance <30 ml/min.
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 |
|---|---|---|
| RemdesivirAlso: VekluryRemdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days | Drug | Remdesivir |
| Standard of care_1Also: PlaquenilHydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days | Drug | Standard of care therapy |
| Standard of care_2Also: SteroidMethylprednisolone 1-2mg/kg for 5-7 days | Drug | Standard of care therapy |
Primary outcome
Evaluation of viral clearance
Time frame: 14 days
Achievement of two successive negative COVID-19 PCR analysis tests 72 hours apart
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 22 Apr 2021.
- 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.
Hany E Dabbous, M.D principal investigator
Faculty of Medicine Ain Shams University
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 Remdesivir in people with Covid19, run by Ain Shams 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 12 inclusion and 6 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 22 Apr 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 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?
Evaluation of viral clearance (time frame: 14 days). 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 22 Apr 2021.