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SARS-CoV InfectionEarly Phase 1RC19LGHNCT04560231

Remdesivir in COVID-19 Lahore General Hospital

A Early Phase 1 study testing Remdesivir in people with SARS-CoV Infection, run by Lahore General Hospital at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Remdesivir is a monophosphoramidate prodrug of an adenosine analogue and it has a broad-spectrum antiviral activity against paramyxoviruses, falviviruses and coronaviruses. It showed in vitro activity on human airway epithelial cells against SARS-CoV-2. Read more about this study

Who is it for?
Ages 15 to 80 years
Conditions the study is for
SARS-CoV Infection
What is being tested?
Remdesivir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 sitePakistan
Study dates
1 Jun 2020to 30 Nov 2020
Phase
Early Phase 1
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 15 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • All patients of all ages, males, and females who will be diagnosed COVID-19 positive by RT-PCR with moderate illness.
  • Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT chest.
  • Respiratory rate > 22/ min and >50% of radiological involvement of lung with typical lesions.
  • FiO2 remain static or improving along with > 30% deranged ≥ 2 biochemical markers CRP > 20 mg/l, LDH > 600 U/L, D.Dimer > 0.5mg/l or 500 ng/ml, Serum Ferritin < 500 ng/ml or mcg/l will be included in clinical trial.

Who cannot join

  • Patients on Invasive mechanical ventilation (IMV).
  • Patients with respiratory rate < 20/mins and whose laboratory findings will not be deranged > 20%.
  • Presences of chronic renal failure > 4 stage, GFR < 30ml/min/1.73m2.
  • ALT/AST > 5 times than normal values.
  • Pregnant women.

Trial locations and contacts

1 site in 1 country.

Muhammad Irfan Malik, FCPS contact

03334367220

drmirfanmalik@hotmail.com

Sardar Al-Fareed Zafar, FCPS contact

03214056891

alfareedivf@hotmail.com

Pakistan1 site, 1 recruiting

  • Muhammad Irfan Malik

    Lahore, Punjab Province, 54500

    Muhammad Irfan Malik, FCPS, 03334367220, drmirfanmalik@hotmail.com

    Sardar Al-Fareed Zafar, FCPS, 03214056891, alfareedivf@hotmail.com

    Recruiting

Other trials in Pakistan

About this study

Official title: Is Remdesivir a Possible Therapeutic Option for SARS-CoV-2 : An Interventional Study

Remdesivir is a monophosphoramidate prodrug of an adenosine analogue and it has a broad-spectrum antiviral activity against paramyxoviruses, falviviruses and coronaviruses. It showed in vitro activity on human airway epithelial cells against SARS-CoV-2. It is an investigational drug and granted an Emergency Use Authorization by Food and Drug Administration FDA, so it is under clinical trial.

The potent mechanism of action of this drug is still unclear but it effects through several processes. It can interfere with nsp12 polymerase even when exoribonuclease proofreading is intact. It can also produce nucleoside triphosphate NTP that acts pharmacologically active alternate substrate of RNA-chain terminator, as a result NTP can constrain active triphosphates into viral RNA of coronaviruses. There is evidence of high genetic barrier to develop resistance against Remdesivir in coronavirus as a result of which is maintains its effectiveness in antiviral therapies against these viruses. Effectiveness of Remdesivir has been reported against different groups of coronaviruses including Alphacoronavirus NL63 and several SARS/MERS-CoV coronaviruses.

Read the detailed description

This is interventional single-center study, that will be done at Lahore General Hospital in which 95 beds are allocated for COVID-19 patients including ICUs and HDUs. Ethical approval will be obtained from research ethical committee of Lahore General hospital, Lahore. Informed consent will be obtained from all patients who will agree to publish their data in this research. Patient's privacy protection will be obeyed with the Helsinki Declaration.

The aim of this study is to evaluate clinical effectiveness of this investigational drug, started a clinical trial of this drug on laboratory-confirmed COVID-19 patients at a tertiary care hospital of Lahore, Pakistan.

Being tested
Remdesivir
Keywords
COVID-19, Remdesivir
Medical subject headings
Severe Acute Respiratory Syndrome, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemdesivirDrug

    Also called Remidia

    200 mg I/v Remdesivir will be given to moderate disease patients of COVID-19. It will be loading dose then 100 mg I/V dose will be given for 5 days. Customized decision for Remdesivir dosage will be made by attending infectious diseases physician, comfort with usage, bacterial co-infection and duration of Ventilation and dose will be extended up to 10 days according to clinical condition of the patients.

Study groups in NCT04560231
Study groupRoleWhat they receive
Group intervene with RemdesivirExperimentalReview effect of Remdesivir as clinical trial among hospitalized patients with COVID-19 infection. 200 mg I/v Remdesivir will be given to moderate disease patients of COVID-19. It will be loading dose then 100 mg I/V dose will be given for 5 days. Customized decision for Remdesivir dosage will be made by attending infectious diseases physician, comfort with usage, bacterial co-infection and duration of Ventilation and dose will be extended up to 10 days according to clinical condition of the patients.
Receives: Drug: Remdesivir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical response after administration

    Clinical improvement of COVID-19 patients by Remdesivir.

    Measured: 10 days

Secondary outcomes (3)

  1. Clinical response to treatment

    Overall survival of COVID-19 patients after drug administration.

    Measured: 15 days

  2. Duration of hospitalization

    Number of days of hospital admission either in ICU or HDUs till date of discharge

    Measured: 15 days

  3. Supplemental Oxygen Requirement from Baseline

    Duration of increased supplemental oxygen requirement from baseline

    Measured: 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2020
  2. Study start1 Jun 2020
  3. Primary completion30 Nov 2020 (estimated)
  4. Study completion30 Nov 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Qausi-experimental
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04560231
Sponsor's protocol ID
LGH003
Acronym
RC19LGH
Status last verified
Sep 2020
First submitted
11 Jul 2020
Last updated
25 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang Y, Zhang D, Du G, Du R, Zhao J, Jin Y, Fu S, Gao L, Cheng Z, Lu Q, Hu Y, Luo G, Wang K, Lu Y, Li H, Wang S, Ruan S, Yang C, Mei C, Wang Y, Ding D, Wu F, Tang X, Ye X, Ye Y, Liu B, Yang J, Yin W, Wang A, Fan G, Zhou F, Liu Z, Gu X, Xu J, Shang L, Zhang Y, Cao L, Guo T, Wan Y, Qin H, Jiang Y, Jaki T, Hayden FG, Horby PW, Cao B, Wang C. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2020 May 16;395(10236):1569-1578. doi: 10.1016/S0140-6736(20)31022-9. Epub 2020 Apr 29.

    PubMed 32423584

  • Davies M, Osborne V, Lane S, Roy D, Dhanda S, Evans A, Shakir S. Remdesivir in Treatment of COVID-19: A Systematic Benefit-Risk Assessment. Drug Saf. 2020 Jul;43(7):645-656. doi: 10.1007/s40264-020-00952-1.

    PubMed 32468196

  • Li Z, Wang X, Cao D, Sun R, Li C, Li G. Rapid review for the anti-coronavirus effect of remdesivir. Drug Discov Ther. 2020;14(2):73-76. doi: 10.5582/ddt.2020.01015.

    PubMed 32378648

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Remdesivir in people with SARS-CoV Infection, run by Lahore General Hospital 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 4 inclusion and 5 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 25 Sep 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 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 Muhammad Irfan Malik, FCPS (03334367220, drmirfanmalik@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical response after administration (time frame: 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04560231, which also lists 3 linked publications.

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 25 Sep 2020.

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