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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-15

Study Completion Date

2021-02-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Covid19 Covid-19 ARDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: Remdesivir + Tocilizumab treatment group

Drug: 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.

Group Type EXPERIMENTAL

Remdesivir

Intervention Type DRUG

Remdesivir 100 IV Infusion as a lyophilized powder

Tocilizumab

Intervention Type DRUG

Actemra IV Infusion

Group B: Control group

Treatment as given without Remdesivir and Tocilizumab.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Remdesivir

Remdesivir 100 IV Infusion as a lyophilized powder

Intervention Type DRUG

Tocilizumab

Actemra IV Infusion

Intervention Type DRUG

Other Intervention Names

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Actemra IV Infusion

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

* 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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No