Covid19, Covid-19 ARDS
Conditions
Keywords
COVID 19, Remdesivir, Ticilizumab, COVID-19 ARDS
Brief 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). Our aim is to find the best option for the treatment and management of ARDS in COVID-19 patients.
Interventions
DRUGRemdesivir
Remdesivir 100 IV Infusion as a lyophilized powder
DRUGTocilizumab
Actemra IV Infusion
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
Cox's Bazar 250 Bed District Sadar Hospital
Chattogram General Hospital
M Abdur Rahim Medical College and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Clinical Improvement (TTCI) | Following randomization 30 days. | Time to Clinical Improvement (TTCI) Defined as Time from Randomization to National Early Warning Score 2 (NEWS2) Score of \</= 2 Maintained for 24 Hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality Rate | Following randomization 30 days. | Mortality Rate on Days during hospitalization |
| Time to Recovery | Following randomization 30 days. | Defined as Time from Randomization to the Time when a Non-ICU Hospital Ward or not Requiring Supplemental Oxygen, or Better is Observed |
| Duration of ICU Stay | Following randomization 30 days. | Duration of ICU Stay in Days |
| Rate of daily Supplemental Oxygen Use | Following randomization 30 days. | Rate of daily Supplemental Oxygen Use by the patient |
| Time to Clinical Failure | Following randomization 30 days. | Time to Clinical Failure, Defined as the Time from Randomization to the First Occurrence of Death, Mechanical Ventilation or Withdrawal (whichever occurs first) |
| Hospital stay | Following randomization 30 days. | 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) |
Countries
Bangladesh
Outcome results
None listed