Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications

NCT04374487 | Unknown Phase 2

• 1 other identifier: MHC-COVID-19-CP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The novel coronavirus disease (COVID-19), which began in Wuhan, China, in December 2019, has been declared to be a pandemic by the World Health Organization (WHO), Caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), COVID-19 has resulted in 1,781,127 cases and 108,994 deaths globally (till 12th April, 2020), affecting 199 countries and 2 international conveyances. US FDA has recently approved Convalescent Plasma from patients recovered from COVID 19 for the treatment of severe or life threatening COVID-19 infections. In a small case series, five critically ill COVID-19 patients with ARDS were treated with convalescent plasma containing neutralizing antibodies. Infusion of plasma was followed by improvement in clinical status in all five patients, with no deaths and the study reported that three patients were discharged, whilst two continued to be stable on mechanical ventilation. We designed this phase II, open label, randomized clinical trial with the primary objective to assess the safety and efficacy of the therapy in the second stage.

Conditions

COVID 19

Outcome Measures

Primary Outcomes (1)

• The primary outcome is a composite measure of the avoidance of - 1. Progression to severe ARDS (P/F ratio 100) and 2. All-cause Mortality at 28 days

  Baseline data about the demography, clinical presentations, ongoing medical therapy, and clinical history of participants in both arms will be collected and compared. Response to convalescent plasma will be coded as a binary outcome - based on whether the composite primary end point is met or not. All the statistical tests will be done at 5% level of significance and SPSS21 will be used for calculations.

  depends on the total treatment time of the subjects within one year period of the trial.

Secondary Outcomes (9)

• Time to symptom resolution-Fever,Shortness of Breath,Fatigue

  one year

• Hospital length of stay

  one year

• Change in SOFA pre and post transfusion

  one year

• Duration of respiratory support required a. Duration of Invasive Mechanical Ventilation b. Duration of Non-Invasive

  one year

• Radiological improvement

  one year

Study Arms (2)

Test Arm

EXPERIMENTAL

50 subjects will be randomized in this arm. Patients in the test group will receive convalescent plasma.

Drug: Convalescent Plasma

Control Arm

OTHER

50 subjects will be randomized in this arm and will be treated according to the standard care. The Ministry of Health and Welfare has issued detailed guidelines for the management of sCOVID-19 based on varying grades of severity. For the management of ARDS or sepsis, the respective guidelines issued by ARDSNet and Surviving Sepsis campaign will be followed. Other institutional protocols for supportive management will be implemented.

Other: Standard Care Therapy

Interventions

Convalescent Plasma DRUG

200 ml of ABO compatible plasma transfusion will be done to the subject randomized for the test arm therapy

Test Arm

Standard Care Therapy OTHER

Subjects randomized to control group will be on standard care treatment according to Institutional Protocols.

Control Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients admitted with RT-PCR confirmed COVID-19 illness. 2. Age \> 18 years 3. Written informed consent 4. Has any of the two
• PaO2/ FiO2 \<300
• Respiratory Rate \> 24/min and SaO2 \< 93% on room air
• Or In case of Severe or immediately life-threatening COVID-19, for example:
• a. Severe disease is defined as: i. dyspnea, ii. respiratory frequency ≥ 30/min, iii. blood oxygen saturation ≤ 93%, iv. partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or v. lung infiltrates \> 50% within 24 to 48 hours b. Life-threatening disease is defined as: i. respiratory failure, ii. septic shock, and/or iii. multiple organ dysfunction or failure

You may not qualify if:

• \. Pregnant women 2. Breastfeeding women 3. Known hypersensitivity to blood products 4. Receipt of Pooled Immunoglobulin in last 30 days 5. Participating in any other clinical trial 6. Clinical status precluding infusion of blood products

Sponsors & Collaborators

• Max Healthcare Insititute Limited: lead

Study Sites (1)

Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation)

New Delhi, National Capital Territory of Delhi, 110017, India

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sangeeta Pathak, MBBS,Diploma

  Max Super Speciality Hospital, Saket (DDF)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 5, 2020
• Study Start: May 9, 2020
• Primary Completion: August 9, 2021
• Study Completion: August 9, 2021
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)