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Covid19Phase 3NCT04678739

Efficacy and Safety of Remdesivir and Tociluzumab for the Management of Severe COVID-19: A Randomized Controlled Trial

A Phase 3 study testing Remdesivir and Tocilizumab in people with Covid19 and Covid-19 ARDS, run by M Abdur Rahim Medical College and Hospital at 4 sites in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized clinical trial was designed and intended to evaluate the efficacy of Remdesivir and Tocilizumab as a treatment for severe Acute Respiratory Distress Syndrome (ARDS) caused by Coronavirus disease 2019 (COVID-19). Read more about this study

Who is it for?
Ages 16 to 80 years
Conditions the study is for
Covid19, Covid-19 ARDS
What is being tested?
Remdesivir and Tocilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
205 participants
Where
4 sitesBangladesh
Study dates
15 Aug 2020to 10 Feb 2021
Phase
Phase 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 16 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Severe COVID-19 patients require hospitalization under HDU/ICU. The SARS-CoV-2 infection will be confirmed by RT PCR / CT Chest in every case.

Who cannot join

  • Participants with uncontrolled clinical status who were hospitalized from the before.
  • Contraindication / possible drug interaction.
  • Participants who have any severe and/or uncontrolled medical conditions like, Severe ischemic heart disease, epilepsy, malignancy, Pulmonary/renal/hepatic disease, AIDS, Pulmonary TB, pregnancy, Corpulmonale, and etc.

Trial locations and contacts

4 sites in 1 country.

Bangladesh4 sites

  • Chattogram General Hospital

    Chittagong, 4000

  • Cox's Bazar 250 Bed District Sadar Hospital

    Cox’s Bāzār

  • M. Abdur Rahim Medical College Hospital

    Dinajpur, 5200

  • M. Abdur Rahim Medical College Hospital

    Dinajpur

Other trials in Bangladesh

About this study

This randomized clinical trial was designed and intended to evaluate the efficacy of Remdesivir and Tocilizumab as a treatment for severe Acute Respiratory Distress Syndrome (ARDS) caused by Coronavirus disease 2019 (COVID-19). Our aim is to find the best option for the treatment and management of ARDS in COVID-19 patients.

Being tested
Remdesivir, Tocilizumab
Keywords
COVID 19, Remdesivir, Ticilizumab, COVID-19 ARDS
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

    Remdesivir 100 IV Infusion as a lyophilized powder

  • TocilizumabDrug

    Also called Actemra IV Infusion

    Actemra IV Infusion

Study groups in NCT04678739
Study groupRoleWhat they receive
Group A: Remdesivir + Tocilizumab treatment groupExperimentalDrug: Remdesivir Injectable solution Tocilizumab Injectable solution A loading dose of Remdesivir I/V 5mg/kg (less than 40kg) or 200mg (>40kg) on day 1, then 2.5mg/kg (less than 40kg) or 100mg (>40kg) daily following randomization. Tocilizumab I/V 8mg/Kg up to 800mg highest 12 hours apart.
Receives: Drug: Remdesivir; Drug: Tocilizumab
Group B: Control groupNo interventionTreatment as given without Remdesivir and Tocilizumab.

What is being measured

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

  1. Time to Clinical Improvement (TTCI)

    Time to Clinical Improvement (TTCI) Defined as Time from Randomization to National Early Warning Score 2 (NEWS2) Score of </= 2 Maintained for 24 Hours.

    Measured: Following randomization 30 days.

Secondary outcomes (6)

  1. Duration of ICU Stay

    Duration of ICU Stay in Days

    Measured: Following randomization 30 days.

  2. Mortality Rate

    Mortality Rate on Days during hospitalization

    Measured: Following randomization 30 days.

  3. Time to Recovery

    Defined as Time from Randomization to the Time when a Non-ICU Hospital Ward or not Requiring Supplemental Oxygen, or Better is Observed

    Measured: Following randomization 30 days.

  4. Hospital stay

    Time from Randomization to Hospital Discharge or "Ready for Discharge" (as Evidenced by Normal Body Temperature and Respiratory Rate, and Stable Oxygen Saturation on Ambient Air or </= 4L Supplemental Oxygen)

    Measured: Following randomization 30 days.

  5. Rate of daily Supplemental Oxygen Use

    Rate of daily Supplemental Oxygen Use by the patient

    Measured: Following randomization 30 days.

  6. Time to Clinical Failure

    Time to Clinical Failure, Defined as the Time from Randomization to the First Occurrence of Death, Mechanical Ventilation or Withdrawal (whichever occurs first)

    Measured: Following randomization 30 days.

Timeline

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

  1. First posted22 Dec 2020
  2. Study start15 Aug 2020
  3. Primary completion30 Jan 2021
  4. Study completion10 Feb 2021

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
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04678739
Sponsor's protocol ID
M.A.R.M.C.D./2020/1985
Status last verified
Mar 2021
First submitted
19 Dec 2020
Last updated
2 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mohiuddin Chowdhury ATM, Kamal A, Abbas KU, Talukder S, Karim MR, Ali MA, Nuruzzaman M, Li Y, He S. Efficacy and Outcome of Remdesivir and Tocilizumab Combination Against Dexamethasone for the Treatment of Severe COVID-19: A Randomized Controlled Trial. Front Pharmacol. 2022 Apr 5;13:690726. doi: 10.3389/fphar.2022.690726. eCollection 2022.

    PubMed 35450050

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remdesivir and Tocilizumab in people with Covid19 and Covid-19 ARDS, run by M Abdur Rahim Medical College and Hospital at 4 sites in Bangladesh.

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 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: finished, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Bangladesh. 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?

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?

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?

Time to Clinical Improvement (TTCI) (time frame: Following randomization 30 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 NCT04678739, which also lists 1 linked publication.

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 2 Apr 2021.

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