Pneumonia, ViralNCT04728880
Remdesivir in Adults With Covid-19: Mansoura University Hospital Experience
An observational study of Pneumonia, Viral, run by Mansoura University at 1 site in Egypt.
Trial summary
COVID-19 is a respiratory disease caused by a new coronavirus (SARS-CoV-2) and causes significant morbidity and mortality. This study is a retrospective trial to assess the efficacy of Remdesivir in adult patients diagnosed with COVID-19 in Mansoura University Isolation Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Viral
- What is being tested?
- Remdesivir
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jan 2021to 30 May 2021
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with COVID-19 in Mansoura University Isolation Hospital.
Who may be able to join
- Adult ≥ 18 years old.
- SARS-CoV-2 infection confirmed.
- Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT chest.
- Hospitalized patients who received at least one administration of Remdesivir therapy (Dose: 200mg day one then 100mg daily for up to 10 days).
Who cannot join
- Presences of chronic renal failure > 4 stage, GFR < 30ml/min.
- ALT/AST > 5 times than normal values.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Hospital
Al Mansurah, Dakahliya, 35511
El Sharawy Kamal, Professor, 002 050 2202876, muh@mans.edu.eg
Mostafa Bakeer, Lecturer
About this study
COVID-19 is a respiratory disease caused by a new coronavirus (SARS-CoV-2) and causes significant morbidity and mortality. This study is a retrospective trial to assess the efficacy of Remdesivir in adult patients diagnosed with COVID-19 in Mansoura University Isolation Hospital. In this study the investigators will analyze the data collected during treatment.
Read the detailed description
COVID-19 is a novel respiratory disease caused by coronavirus (SARS-CoV-2) and results in significant morbidity and mortality. To date there is no approved medication for the treatment of patients with COVID-19. Remdesivir is a broad-spectrum antiviral nucleotide analogue that inhibits RNA-dependent RNA polymerase activity among a diverse group of RNA viruses. Non-clinical and clinical data suggest that Remdesivir may be useful for the treatment of COVID-19. WHO has identified Remdesivir as a candidate drug of interest to be studied in clinical trials. This retrospective study is designed to analyze the data collected during the routine care of patients who have benefited from this therapy.
- Conditions
- Pneumonia, Viral
- Being tested
- Remdesivir
- Medical subject headings
- Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemdesivirDrug
This study is a retrospective trial to assess the efficacy of Remdesivir in adult patients diagnosed with COVID-19 in Mansoura University Isolation Hospital. In this study we will analyze the data collected during treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Pulse rate
Change from baseline in the pulse rate during clinical course of patients on Day 15 under treatment with Remdesivir.
Measured: 15 days
Change from baseline in respiratory rate
Change from baseline in the respiratory rate during clinical course of patients on Day 15 under treatment with Remdesivir.
Measured: 15 days
Change from baseline in body core temperature
Change from baseline in the body core temperature during clinical course of patients on Day 15 under treatment with Remdesivir.
Measured: 15 days
Change from baseline in blood pressure
Change from baseline in the blood pressure during clinical course of patients on Day 15 under treatment with Remdesivir.
Measured: 15 days
Change from baseline in arterial blood gas analyses
Change from baseline in the arterial blood gas analyses during clinical course of patients on Day 15 under treatment with Remdesivir.
Measured: 15 days
Change from baseline in Spo2 / FIO2 ratio
Change from baseline in the Spo2 / FIO2 ratio during clinical course of patients on Day 15 under treatment with Remdesivir.
Measured: 15 days
Change from baseline in White blood cell count
Change from baseline in the White blood cell count during clinical course of patients on Day 15 under treatment with Remdesivir.
Measured: 15 days
Change from baseline in lymphocyte count
Change from baseline in the lymphocyte count during clinical course of patients on Day 15 under treatment with Remdesivir.
Measured: 15 days
Change from baseline in lactate dehydrogenase
Change from baseline in the lactate dehydrogenase during clinical course of patients on Day 15 under treatment with Remdesivir.
Measured: 15 days
Change from baseline in D-dimer
Change from baseline in the D-dimer during clinical course of patients on Day 15 under treatment with Remdesivir.
Measured: 15 days
Change from baseline in procalcitonin
Change from baseline in the procalcitonin during clinical course of patients on Day 15 under treatment with Remdesivir.
Measured: 15 days
Change from baseline in Interleukin-6
Change from baseline in the Interleukin-6 during clinical course of patients on Day 15 under treatment with Remdesivir.
Measured: 15 days
Change from baseline in Serum ferretin
Change from baseline in the Serum ferretin during clinical course of patients on Day 15 under treatment with Remdesivir.
Measured: 15 days
Change from baseline in prothrombin time
Change from baseline in the prothrombin time during clinical course of patients on Day 15 under treatment with Remdesivir.
Measured: 15 days
Change from baseline in serum creatinine
Change from baseline in the serum creatinine during clinical course of patients on Day 15 under treatment with Remdesivir.
Measured: 15 days
Change from baseline in liver enzyme ALT
Change from baseline in the liver enzyme ALT during clinical course of patients on Day 15 under treatment with Remdesivir.
Measured: 15 days
Change from baseline in creatinine kinase
Change from baseline in the creatinine kinase during clinical course of patients on Day 15 under treatment with Remdesivir.
Measured: 15 days
Change from baseline in cardiac troponin
Change from baseline in the cardiac troponin during clinical course of patients on Day 15 under treatment with Remdesivir.
Measured: 15 days
Change from baseline in The Sequential Organ Failure Assessment score (SOFA score)
The Sequential Organ Failure Assessment (SOFA) is a morbidity severity score and mortality estimation tool. It allows for calculation of both the number and the severity of organ dysfunction in six organ systems (respiratory, coagulatory, liver, cardiovascular, renal, and neurologic). The following values are used to calculate the score: (PaO2 / FiO2 and artificial ventilation; platelets; bilirubin; average blood pressure and use of vasoactive drugs; creatinine).The total score ranges from 0-24. Zero indicates low risk while 24 indicates higher risk of mortality.
Measured: 15 days
Secondary outcomes (4)
Duration of hospitalization
Number of days of hospital admission either in ICU or ward till date of discharge
Measured: 15 days
Supplemental Oxygen Requirement from Baseline
Duration of increased supplemental oxygen requirement from baseline
Measured: 15 days
Duration without mechanical ventilation
Duration without mechanical ventilation within 15 days of initiation of treatment with Remdesivir
Measured: 15 days
Mortality
Mortality at 15 days after initiation of treatment with Remdesivir.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start26 Jan 2021 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, ViralStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Bakeer, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728880
- Sponsor's protocol ID
- R.20.11.1097
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2021
- Last updated
- 28 Jan 2021
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remdesivir in Adults With Covid-19: Mansoura University Hospital Experience
- ClinicalTrials.gov ID
- NCT04728880
- Acronym / sponsor ID
- R.20.11.1097
- Conditions
- Pneumonia, Viral
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 26 Jan 2021 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 28 Jan 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.
COVID-19 is a respiratory disease caused by a new coronavirus (SARS-CoV-2) and causes significant morbidity and mortality. This study is a retrospective trial to assess the efficacy of Remdesivir in adult patients diagnosed with COVID-19 in Mansoura University Isolation Hospital. In this study the investigators will analyze the data collected during treatment.
Detailed description
COVID-19 is a novel respiratory disease caused by coronavirus (SARS-CoV-2) and results in significant morbidity and mortality. To date there is no approved medication for the treatment of patients with COVID-19. Remdesivir is a broad-spectrum antiviral nucleotide analogue that inhibits RNA-dependent RNA polymerase activity among a diverse group of RNA viruses. Non-clinical and clinical data suggest that Remdesivir may be useful for the treatment of COVID-19. WHO has identified Remdesivir as a candidate drug of interest to be studied in clinical trials. This retrospective study is designed to analyze the data collected during the routine care of patients who have benefited from this therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with COVID-19 in Mansoura University Isolation Hospital.
Key inclusion criteria (4 listed)
- Adult ≥ 18 years old.
- SARS-CoV-2 infection confirmed.
- Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT chest.
- Hospitalized patients who received at least one administration of Remdesivir therapy (Dose: 200mg day one then 100mg daily for up to 10 days).
Key exclusion criteria (3 listed)
- Presences of chronic renal failure > 4 stage, GFR < 30ml/min.
- ALT/AST > 5 times than normal values.
- Pregnant women.
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 |
|---|---|---|
| RemdesivirThis study is a retrospective trial to assess the efficacy of Remdesivir in adult patients diagnosed with COVID-19 in Mansoura University Isolation Hospital. In this study we will analyze the data collected during treatment. | Drug | – |
Primary outcome
Change from baseline in Pulse rate
Time frame: 15 days
Change from baseline in the pulse rate during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in respiratory rate
Time frame: 15 days
Change from baseline in the respiratory rate during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in body core temperature
Time frame: 15 days
Change from baseline in the body core temperature during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in blood pressure
Time frame: 15 days
Change from baseline in the blood pressure during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in arterial blood gas analyses
Time frame: 15 days
Change from baseline in the arterial blood gas analyses during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in Spo2 / FIO2 ratio
Time frame: 15 days
Change from baseline in the Spo2 / FIO2 ratio during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in White blood cell count
Time frame: 15 days
Change from baseline in the White blood cell count during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in lymphocyte count
Time frame: 15 days
Change from baseline in the lymphocyte count during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in lactate dehydrogenase
Time frame: 15 days
Change from baseline in the lactate dehydrogenase during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in D-dimer
Time frame: 15 days
Change from baseline in the D-dimer during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in procalcitonin
Time frame: 15 days
Change from baseline in the procalcitonin during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in Interleukin-6
Time frame: 15 days
Change from baseline in the Interleukin-6 during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in Serum ferretin
Time frame: 15 days
Change from baseline in the Serum ferretin during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in prothrombin time
Time frame: 15 days
Change from baseline in the prothrombin time during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in serum creatinine
Time frame: 15 days
Change from baseline in the serum creatinine during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in liver enzyme ALT
Time frame: 15 days
Change from baseline in the liver enzyme ALT during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in creatinine kinase
Time frame: 15 days
Change from baseline in the creatinine kinase during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in cardiac troponin
Time frame: 15 days
Change from baseline in the cardiac troponin during clinical course of patients on Day 15 under treatment with Remdesivir.
Change from baseline in The Sequential Organ Failure Assessment score (SOFA score)
Time frame: 15 days
The Sequential Organ Failure Assessment (SOFA) is a morbidity severity score and mortality estimation tool. It allows for calculation of both the number and the severity of organ dysfunction in six organ systems (respiratory, coagulatory, liver, cardiovascular, renal, and neurologic). The following values are used to calculate the score: (PaO2 / FiO2 and artificial ventilation; platelets; bilirubin; average blood pressure and use of vasoactive drugs; creatinine).The total score ranges from 0-24. Zero indicates low risk while 24 indicates higher risk of mortality.
4 secondary outcomes
Duration of hospitalization
Time frame: 15 days
Supplemental Oxygen Requirement from Baseline
Time frame: 15 days
Duration without mechanical ventilation
Time frame: 15 days
Mortality
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Viral, run by Mansoura 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 4 inclusion and 3 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 28 Jan 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Pulse rate (time frame: 15 days). The study lists 19 primary outcomes in all. 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 28 Jan 2021.