Efficacy of Convalescent Plasma Therapy in Severely Sick COVID-19 Patients

NCT04346446 | Completed Phase 2

• 1 other identifier: ILBS-COVID-02
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

Currently, no effective treatments are available for the COVID-19 pandemic, which is related to more than 70,000 deaths all over the world. Scientists and Researchers are working on many aspects of treatment options for the development of vaccination and medication to combat this life-threatening problem. Convalescent plasma from recovered COVID-19 patients contains antibodies against COVID-19 which may be beneficial to severely sick COVID019 infected patients. We have planned a randomized controlled trial to assess the efficacy of this therapy in COVID-19 infected sick patients. We will collect up to 500 ml Convalescent Plasma from the COVID-19 infected recovered patient after 14 days of clinical and radiological recovery with two consecutive COVID-19 negative tests by PCR. We will further test the sample from the collected plasma for COVID-19 specific antibodies and their titer. This plasma will be frozen and sent to the treating center (MAMC). 200-600 ml of convalescent plasma will be transfused to patients who fit the eligibility criteria and are randomized to the convalescent plasma group. This will be done in severely sick patients. Data will be collected for the benefit and adverse events related to convalescent plasma transfusion.

Conditions

COVID

Keywords

convalescent plasma,COVID,SARS-COV -2

Outcome Measures

Primary Outcomes (1)

• Proportion of patients remaining free of mechanical ventilation in both groups

  Day 7

Secondary Outcomes (9)

• Mortality in both groups

  Day 28

• Improvement in Pa02/Fi02 ratio in both groups

  Day 2

• Improvement in Pa02/Fi02 ratio in both groups

  Day 7

• Improvement in SOFA score in both groups

  Day 2

• Improvement in SOFA score in both groups

  Day 7

Study Arms (2)

Convalescent Plasma+Supportive Care

EXPERIMENTAL

Convalescent Plasma+Supportive Care Convalescent plasma from recovered COVID-19 patients will be transfused to severely sick COVID-19 infected patients

Drug: Convalescent Plasma Transfusion; Other: Supportive Care

Random Donor Plasma+Supportive Care

ACTIVE COMPARATOR

Random Donor Plasma+Supportive Care

Other: Supportive Care; Drug: Random Donor Plasma

Interventions

Convalescent Plasma Transfusion DRUG

Convalescent Plasma Transfusion

Convalescent Plasma+Supportive Care

Supportive Care OTHER

Supportive Care

Convalescent Plasma+Supportive Care; Random Donor Plasma+Supportive Care

Random Donor Plasma DRUG

Random Donor Plasma will be transfuse from 200 to 600 mL according to the patient requirement

Random Donor Plasma+Supportive Care

Eligibility Criteria

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

You may qualify if:

• Recipient:
• Severe COVID -19 infections defined as WHO Interim Guidance and the Guideline of Diagnosis and Treatment of COVID-19 of National Health Commission of China (version 5.0) with confirmation by real-time RT-PCR assay with severe disease i.e. meeting any 2 of the following criteria-
• Respiratory distress, RR ≥30 beats/min
• Oxygen saturation level less than 93% in resting state
• Partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) ≤ 300 mmHg.
• Lung infiltrates \> 50% within 24 to 48 hours
• Very sick (on ventilator) and patients with co-morbidities such as patients with known co-morbid diseases (COPD, CAD, CLD, CKD, cardiopulmonary disease-structural or valvular heart disease)
• Patient presenting with multi organ failure or requiring mechanical ventilation.
• Donor:
• Known case of recovered COVID-19 Infection, and
• Complete resolution of symptoms at least 28 days prior to donation or Complete resolution of symptoms at least 14 days prior to donation and negative results for COVID-19 either from one or more nasopharyngeal swab specimens or by a molecular diagnostic test from the blood, And Negative RT-PCR for COVID-19 on two sequential paired nasopharyngeal and throat specimens \> 24 hrs apart (WHO-CDC guideline).
• Donor Plasma after 2 negative tests and 2 weeks of remaining asymptomatic, without antibody titre \& presence of IgG/IgM antibodies to COVID-19 by serological as per manufacturers instructions. Donors negative for these will be deferred).
• Fulfill all criteria of donor eligibility for donor Plasmapheresis under the Drugs \& Cosmetics Act and Rules 1945, amended 11.03.2020.

You may not qualify if:

• \- Recipient
• Patients with age less than 18 years.
• Pregnancy
• Individual with HIV and Hepatitis
• Morbid Obesity BMI\>35 kg/m2
• Extremely moribund patients with an expected life expectancy of less than 24 hours.
• Failure to give informed consent from the patient or family members.
• Hemodynamic instability requiring vasopressors.
• Previous allergic history to plasma.
• Donor:
• Donors age \< 18 \& ≥60 years old
• Do not fulfil all criteria of donor eligibility for donor Plasmapheresis under the Drugs \& Cosmetics Act and Rules 1945, amended 11.03.2020.
• Females who have been pregnant and previously transfused donors (to prevent TRALI).
• Donors who have taken steroids during treatment for COVID-19.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (2)

Maulana Azad medical College

New Delhi, National Capital Territory of Delhi, 110002, India

Location

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Related Publications (3)

• Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.

  PMID: 37162745 DERIVED

• Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.

  PMID: 36734509 DERIVED

• Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.

  PMID: 34013969 DERIVED

MeSH Terms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

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 14, 2020
• First Posted: April 15, 2020
• Study Start: April 20, 2020
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2020
• Last Updated: June 12, 2020

Record last verified: 2020-06

Locations

IN (2)