COVIDPhase 2/3NCT04460443
Sofosbuvir in Treatment of COVID 19
A Phase 2/3 study testing sofosbuvir, Sofosbuvir ledipsavir and Daclatasvir in people with COVID, run by Tanta University at 1 site in Egypt.
Trial summary
Sofosbuvir containing treatment in treatment of COVID 19 Egyptian patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID
- What is being tested?
- sofosbuvir, Sofosbuvir ledipsavir and Daclatasvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 31 Aug 2021
- 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 positive patients.
Who cannot join
- Contraindication to sofosbuvir or ribavirin.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Tanta
Sherief Abd-Elsalam, Ass. Prof., 00201009221243, sheriefabdelsalam@yahoo.com
About this study
Official title: Sofosbuvir Based Regimens in Treatment of COVID 19 Patients
Sofosbuvir containing treatment in treatment of COVID 19 Egyptian patients
Read the detailed description
Sofosbuvir containing treatment of COVID 19 Egyptian patients: a randomized-controlled trial
- Conditions
- COVID
- Being tested
- sofosbuvir, Sofosbuvir ledipsavir, Daclatasvir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sofosbuvirDrug
Also called Mpiviropack, Sovaldy, soflanork
Sofosbuvir once daily
Sofosbuvir ledipsavirDrug
Also called mpiviropack plus
Sofosbuvir ledipsavir once daily
DaclatasvirDrug
Also called daklinza
Daklatasuvir tablets
| Study group | Role | What they receive |
|---|---|---|
| Sofosbuvir and ledipsavir | Experimental | Sofosbuvir and ledipsavir plus standard of care treatment. Receives: Drug: Sofosbuvir ledipsavir |
| Sofosbuvir and Daklatasuvir | Experimental | Sofosbuvir and Daklatasuvir plus standard of card treatment.. Receives: Drug: sofosbuvir; Drug: Daclatasvir |
| Standard treatment | No intervention | Standard treatment alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with response to treatment
The total number of patients with response to treatment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Aug 2020
- Primary completion1 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Marwa Salama, Consultant, Principal investigator, Tanta University - Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460443
- Sponsor's protocol ID
- sofosbuvir
- Status last verified
- Dec 2020
- First submitted
- 4 Jul 2020
- Last updated
- 8 Dec 2020
- 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 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sofosbuvir Based Regimens in Treatment of COVID 19 Patients
- ClinicalTrials.gov ID
- NCT04460443
- Acronym / sponsor ID
- sofosbuvir
- Conditions
- COVID
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 7 Jul 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.
Sofosbuvir containing treatment in treatment of COVID 19 Egyptian patients
Detailed description
Sofosbuvir containing treatment of COVID 19 Egyptian patients: a randomized-controlled trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sofosbuvir and ledipsavir | Experimental | Drug: Sofosbuvir ledipsavirSofosbuvir and ledipsavir plus standard of care treatment. |
| Sofosbuvir and Daklatasuvir | Experimental | Drug: sofosbuvir, Drug: DaclatasvirSofosbuvir and Daklatasuvir plus standard of card treatment.. |
| Standard treatment | No intervention | –Standard treatment alone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Covid positive patients.
Key exclusion criteria (1 listed)
- Contraindication to sofosbuvir or ribavirin.
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 |
|---|---|---|
| sofosbuvirAlso: Mpiviropack, Sovaldy, soflanorkSofosbuvir once daily | Drug | Sofosbuvir and Daklatasuvir |
| Sofosbuvir ledipsavirAlso: mpiviropack plusSofosbuvir ledipsavir once daily | Drug | Sofosbuvir and ledipsavir |
| DaclatasvirAlso: daklinzaDaklatasuvir tablets | Drug | Sofosbuvir and Daklatasuvir |
Primary outcome
Number of patients with response to treatment
Time frame: 1 month
The total number of patients with response to treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- 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.
Marwa Salama, Consultant 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 sofosbuvir, Sofosbuvir ledipsavir and Daclatasvir 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: status not confirmed, as of the sponsor's last update on 8 Dec 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, ass. prof. (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with response to treatment (time frame: 1 month). 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 8 Dec 2020.