COVID-19NCT04871633
Effectiveness of Remedesvir in COVID-19 Patients Presenting at Mayo Hospital Lahore
A study testing Remdesivir and Conventional in people with COVID-19, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
Currently, several drugs including Remdesivir, hydroxychloroquine, chloroquine, ritonavir+lopinavir, Tocilizumab, Arbidol and interferon are under randomised controlled trials (RCTs) for efficacy and/or safety evaluations in patients with COVID-19 in different countries. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Remdesivir and Conventional
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2020to 30 Dec 2020
- Phase
- Interventional
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All Patients with confirmed COVID-19 of either gender and aged 12 years and above.
- Patients having Severe COVID 19 Disease. Severe disease is defined as patients with an oxygen saturation (SpO2) ≤94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO).17
- -
Who cannot join
- Known severe allergic reaction to Remdesivir or to other antiviral drugs
- Patients already having other treatments like tocilizumab or other antiviral drugs
- Pregnancy or breastfeeding
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times upper normal limit
- Creatinine clearance <30ml/min
- Low platelet count <50,000/l
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Remedesvir in SARS-CoV2 Patients Presenting at Mayo Hospital Lahore
Currently, several drugs including Remdesivir, hydroxychloroquine, chloroquine, ritonavir+lopinavir, Tocilizumab, Arbidol and interferon are under randomised controlled trials (RCTs) for efficacy and/or safety evaluations in patients with COVID-19 in different countries. Remdesivir (GS-5734) is among these investigational drugs and some studies reported promising results. Remdesivir is a nucleotide analogue intravenous pro-drug developed by Gilead Sciences, an American biopharmaceutical company, for treatment of Ebola virus during the 2014 Ebola outbreak in Western Africa. Remdesivir shows broad-spectrum antiviral activity against many RNA viruses including SARS-CoV-2 through blocking RNA polymerase thereby terminating RNA transcription. Remdesivir was among the first treatments used in China as the outbreak emerges and it has been reported as potential treatment options for COVID-19 in the USA, China and Italy.
Read the detailed description
Coronavirus diseases 2019 (COVID-19) is caused by a novel β-coronavirus which is named as SARS-CoV-2. SARS-CoV-2 shares 79% RNA sequence identity with severe acute respiratory syndrome coronavirus 2 (SARS-COV2) and 50% genomic sequence identity with Middle East respiratory syndrome coronavirus (MERS-CoV) which caused a major outbreak since 2002 and 2012 in China and Saudi Arabia, respectively. Despite global containment measures to fight the disease, the pandemic continued to rise, rapidly spread across the world, and resulting in in 10.5 million confirmed cases and 51391 deaths worldwide as of July 1st 2020. The outbreak of COVID-19 infection has a significant threat to international health, the economy, psychological stress and mental health worldwide. Yet, there are no approved vaccines or drugs to make the disease less deadly; implying that searching therapeutic options are critical issues to overcome the outbreak. Studies are strongly underway to discover rapidly drug candidates for COVID-19, and studies are looking into repurposing drugs that have been used for the treatment of other diseases.
Pakistan is badly facing this pandemic too. Up till now there are 221,896 confirmed cases with 4551 deaths with a death ratio of 2.1%. More than 3000 patients are critical.8 In Punjab, being allocated as a leading tertiary care centre for COVID-19 patients, Mayo hospital Lahore is dealing with each and every category of COVID-19 patients with variable presentations and treating those patients with different investigational drugs in keeping with other countries to find the best possible treatable drug.
US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) of the antiviral drug remdesivir for the treatment of patients with COVID-19. Although clinical trials have showed remdesivir as a treatment option for COVID-19, results are controversial. That's why we need to conduct a trial in our part of the world too to see its effectiveness in patients presenting with Covid-19.
Remdesivir has been recently approved by CEAG (Corona Expert Advisory Group) for COVID patient is Mayo hospital. Remdesivir has never been used before in any public sector hospital in Punjab. Investigators aim to do this study in Mayo hospital Lahore to check the efficiency of this drug in COVID-19 patients in Mayo hospital Lahore
OBJECTIVE:
The objective of the study is to evaluate the effectiveness of remdesivir in patients with COVID-19 presenting to Mayo Hospital Lahore
OUTCOME AND UTILIZATION:
To date, no therapy has demonstrated efficacy for patients with COVID-19.This study will help in finding any definite role of Remdesivir in COVID -19 patients who are severely ill . Although data from several international ongoing randomized, controlled trials will soon provide more informative evidence regarding the safety and efficacy of remdesivir for COVID-19, but this needs to be evaluated in local arena too.
- Conditions
- COVID-19
- Being tested
- Remdesivir, Conventional
- Keywords
- Remdesvir, Sars CoV-2, Effectiveness
- 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 is an intravenous (IV) loading dose of 200 mg on day 1 followed by daily IV maintenance doses of 100 mg for 5-10 days
ConventionalDrug
Also called Solumedrol, dexamethasone,prednisolone, azithromycin
IV Steroids Antibiotics
| Study group | Role | What they receive |
|---|---|---|
| Remdesivir | Active comparator | patients having drug Remdesivir in addition to conventional treatment according to disease grade (steroids, anticoagulants, antibiotics if needed, oxygen therapy, paracetamol, antihistamine) Receives: Drug: Remdesivir; Drug: Conventional |
| Conventional | Other | patients having Standard Conventional therapy only. Receives: Drug: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Stay
Duration of stay in hospital in days
Measured: 10 days
Ventilation
No of patients needing IPPV
Measured: 10 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 Aug 2020
- Primary completion15 Nov 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871633
- Sponsor's protocol ID
- 483/RC/KEMU
- Status last verified
- May 2021
- First submitted
- 11 Jan 2021
- Last updated
- 4 May 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 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Remedesvir in SARS-CoV2 Patients Presenting at Mayo Hospital Lahore
- ClinicalTrials.gov ID
- NCT04871633
- Acronym / sponsor ID
- 483/RC/KEMU
- Conditions
- COVID-19
- Keywords
- Remdesvir, Sars CoV-2, Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 4 May 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.
Currently, several drugs including Remdesivir, hydroxychloroquine, chloroquine, ritonavir+lopinavir, Tocilizumab, Arbidol and interferon are under randomised controlled trials (RCTs) for efficacy and/or safety evaluations in patients with COVID-19 in different countries. Remdesivir (GS-5734) is among these investigational drugs and some studies reported promising results. Remdesivir is a nucleotide analogue intravenous pro-drug developed by Gilead Sciences, an American biopharmaceutical company, for treatment of Ebola virus during the 2014 Ebola outbreak in Western Africa. Remdesivir shows broad-spectrum antiviral activity against many RNA viruses including SARS-CoV-2 through blocking RNA polymerase thereby terminating RNA transcription. Remdesivir was among the first treatments used in China as the outbreak emerges and it has been reported as potential treatment options for COVID-19 in the USA, China and Italy.
Detailed description
Coronavirus diseases 2019 (COVID-19) is caused by a novel β-coronavirus which is named as SARS-CoV-2. SARS-CoV-2 shares 79% RNA sequence identity with severe acute respiratory syndrome coronavirus 2 (SARS-COV2) and 50% genomic sequence identity with Middle East respiratory syndrome coronavirus (MERS-CoV) which caused a major outbreak since 2002 and 2012 in China and Saudi Arabia, respectively. Despite global containment measures to fight the disease, the pandemic continued to rise, rapidly spread across the world, and resulting in in 10.5 million confirmed cases and 51391 deaths worldwide as of July 1st 2020. The outbreak of COVID-19 infection has a significant threat to international health, the economy, psychological stress and mental health worldwide. Yet, there are no approved vaccines or drugs to make the disease less deadly; implying that searching therapeutic options are critical issues to overcome the outbreak. Studies are strongly underway to discover rapidly drug candidates for COVID-19, and studies are looking into repurposing drugs that have been used for the treatment of other diseases.
Pakistan is badly facing this pandemic too. Up till now there are 221,896 confirmed cases with 4551 deaths with a death ratio of 2.1%. More than 3000 patients are critical.8 In Punjab, being allocated as a leading tertiary care centre for COVID-19 patients, Mayo hospital Lahore is dealing with each and every category of COVID-19 patients with variable presentations and treating those patients with different investigational drugs in keeping with other countries to find the best possible treatable drug.
US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) of the antiviral drug remdesivir for the treatment of patients with COVID-19. Although clinical trials have showed remdesivir as a treatment option for COVID-19, results are controversial. That's why we need to conduct a trial in our part of the world too to see its effectiveness in patients presenting with Covid-19.
Remdesivir has been recently approved by CEAG (Corona Expert Advisory Group) for COVID patient is Mayo hospital. Remdesivir has never been used before in any public sector hospital in Punjab. Investigators aim to do this study in Mayo hospital Lahore to check the efficiency of this drug in COVID-19 patients in Mayo hospital Lahore
OBJECTIVE:
The objective of the study is to evaluate the effectiveness of remdesivir in patients with COVID-19 presenting to Mayo Hospital Lahore
OUTCOME AND UTILIZATION:
To date, no therapy has demonstrated efficacy for patients with COVID-19.This study will help in finding any definite role of Remdesivir in COVID -19 patients who are severely ill . Although data from several international ongoing randomized, controlled trials will soon provide more informative evidence regarding the safety and efficacy of remdesivir for COVID-19, but this needs to be evaluated in local arena too.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remdesivir | Active comparator | Drug: Remdesivir, Drug: Conventionalpatients having drug Remdesivir in addition to conventional treatment according to disease grade (steroids, anticoagulants, antibiotics if needed, oxygen therapy, paracetamol, antihistamine) |
| Conventional | Other | Drug: Conventionalpatients having Standard Conventional therapy only. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All Patients with confirmed COVID-19 of either gender and aged 12 years and above.
- Patients having Severe COVID 19 Disease. Severe disease is defined as patients with an oxygen saturation (SpO2) ≤94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO).17
- -
Key exclusion criteria (6 listed)
- Known severe allergic reaction to Remdesivir or to other antiviral drugs
- Patients already having other treatments like tocilizumab or other antiviral drugs
- Pregnancy or breastfeeding
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times upper normal limit
- Creatinine clearance <30ml/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 is an intravenous (IV) loading dose of 200 mg on day 1 followed by daily IV maintenance doses of 100 mg for 5-10 days | Drug | Remdesivir |
| ConventionalAlso: Solumedrol, dexamethasone,prednisolone, azithromycinIV Steroids Antibiotics | Drug | Conventional, Remdesivir |
Primary outcome
Hospital Stay
Time frame: 10 days
Duration of stay in hospital in days
Ventilation
Time frame: 10 Days
No of patients needing IPPV
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 4 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remdesivir and Conventional in people with COVID-19, run by King Edward Medical University at 1 site in Pakistan.
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 3 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 4 May 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 Pakistan. 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?
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?
Hospital Stay (time frame: 10 days). The study lists 2 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 4 May 2021.