Covid19Phase 4NCT04738045
Comparison of Remdesivir Versus Lopinavir/ Ritonavir and Remdesivir Combination in COVID-19 Patients
A Phase 4 study testing Remdesivir and Lopinavir/ Ritonavir and Remdesivir combination in people with Covid19, run by Ahmed Essam at 1 site in Egypt.
Trial summary
Comparison outcomes of a large cohort of moderate and severe COVID-19 patients received remdesivir alone with patients who received remdesivir in combination with lopinavir/ ritonavir in addition to standard management. 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 and Lopinavir/ Ritonavir and Remdesivir combination
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to 1 Apr 2021
- Phase
- Phase 4
- 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
- Hospitalized adult patients with pneumonia evidenced by chest CT scan.
- Laboratory (RT-PCR) confirmed infection with 2019-nCoV or strongly suspected to be infected with SARS-COV2 with confirmation studies pending.
- And at least one of the following:
- Respiratory frequency ≥30/min.
- Blood oxygen saturation ≤93% on room air (RA).
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) <300.
- Worsening of lung involvement, defined as an increase in number and/or extension of pulmonary areas of consolidation, need for increased FiO2 to maintain stable O2 saturation, or worsening O2 saturation of >3% with stable FiO2.
Who cannot join
- Baseline elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 5-fold the upper limit of the normal range.
- Pregnancy.
- Known hypersensitivity to drugs or any component of the formulation.
- Serious co-morbidity, including: Hepatic patients child Pugh class C.
Trial locations and contacts
1 site in 1 country.
Marian Boshra, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Beni-suef University
Banī Suwayf
Rania M Sarhan, PhD
About this study
Official title: Comparative Therapeutic Efficacy and Safety of Remdesivir Versus Lopinavir/ Ritonavir and Remdesivir Combination in COVID-19 Patients
Comparison outcomes of a large cohort of moderate and severe COVID-19 patients received remdesivir alone with patients who received remdesivir in combination with lopinavir/ ritonavir in addition to standard management.
Read the detailed description
Aim of the study
- To assess the difference in patients' clinical status improvement between patients receiving remdesivir alone and patients receiving remdesivir and lopinavir/ ritonavir.
- To detect time to improvement in oxygenation among both groups.
- To detect duration of hospitalization and mortality rate in both groups.
- To detect incidence and duration of mechanical ventilation in both treatment arms.
- To monitor of adverse events of both drugs.
- Conditions
- Covid19
- Being tested
- Remdesivir, Lopinavir/ Ritonavir and Remdesivir combination
- Keywords
- Remdesivir, Lopinavir/ Ritonavir
- 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 control
Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily.
Lopinavir/ Ritonavir and Remdesivir combinationDrug
Also called intervention
Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily for 5 days. Receives: Drug: Remdesivir |
| interventional | Experimental | Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days. Receives: Drug: Lopinavir/ Ritonavir and Remdesivir combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group
Clinical cure will be assessed after 5-7 days from starting treatment based on:
- Improvement in oxygenation (SpO2/FiO2 ratio).
- Time to improvement in oxygenation.
- Duration of hospitalization.
- Mortality rate.
Measured: "through study completion, an average of 3 months"
Secondary outcomes (1)
Monitoring of adverse events.
The occurrence of adverse events will be recorded on a daily basis, with a focus on: bacterial or fungal infections, elevation of AST or ALT level > 3x the upper limit of normal range.
Measured: "through study completion, an average of 3 months"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start1 Nov 2020
- Primary completion28 Mar 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Essam
- Sponsor type
- University, hospital or other
- Collaborators
- Beni-Suef University
- Responsible party
- Sponsor-investigator, Ahmed Essam, October 6 University
- Investigators
- Rania M Sarhan, PhD, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738045
- Sponsor's protocol ID
- REC-H-PhBSU-21001
- Status last verified
- Mar 2021
- First submitted
- 31 Jan 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Therapeutic Efficacy and Safety of Remdesivir Versus Lopinavir/ Ritonavir and Remdesivir Combination in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04738045
- Acronym / sponsor ID
- REC-H-PhBSU-21001
- Conditions
- Covid19
- Keywords
- Remdesivir, Lopinavir/ Ritonavir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ahmed EssamUniversity, hospital or other
- Collaborators
- Beni-Suef University
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 28 Mar 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 4 Feb 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.
Comparison outcomes of a large cohort of moderate and severe COVID-19 patients received remdesivir alone with patients who received remdesivir in combination with lopinavir/ ritonavir in addition to standard management.
Detailed description
Aim of the study
- To assess the difference in patients' clinical status improvement between patients receiving remdesivir alone and patients receiving remdesivir and lopinavir/ ritonavir.
- To detect time to improvement in oxygenation among both groups.
- To detect duration of hospitalization and mortality rate in both groups.
- To detect incidence and duration of mechanical ventilation in both treatment arms.
- To monitor of adverse events of both drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Drug: RemdesivirRemdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily for 5 days. |
| interventional | Experimental | Drug: Lopinavir/ Ritonavir and Remdesivir combinationRemdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hospitalized adult patients with pneumonia evidenced by chest CT scan.
- Laboratory (RT-PCR) confirmed infection with 2019-nCoV or strongly suspected to be infected with SARS-COV2 with confirmation studies pending.
- And at least one of the following:
Key exclusion criteria (4 listed)
- Baseline elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 5-fold the upper limit of the normal range.
- Pregnancy.
- Known hypersensitivity to drugs or any component of the formulation.
- Serious co-morbidity, including: Hepatic patients child Pugh class C.
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: controlRemdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily. | Drug | control |
| Lopinavir/ Ritonavir and Remdesivir combinationAlso: interventionRemdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days | Drug | interventional |
Primary outcome
Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group
Time frame: "through study completion, an average of 3 months"
Clinical cure will be assessed after 5-7 days from starting treatment based on: 1. Improvement in oxygenation (SpO2/FiO2 ratio). 2. Time to improvement in oxygenation. 3. Duration of hospitalization. 4. Mortality rate.
1 secondary outcome
Monitoring of adverse events.
Time frame: "through study completion, an average of 3 months"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
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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.
Marian Boshra, PhD contact
Rania M Sarhan, PhD principal investigator
Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remdesivir and Lopinavir/ Ritonavir and Remdesivir combination in people with Covid19, run by Ahmed Essam 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 7 inclusion and 4 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 17 Mar 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Ahmed E Abou warda, BSc (00201007647696, ahmed.essam@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group (time frame: "through study completion, an average of 3 months"). 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 17 Mar 2021.