Convalescent Plasma To Limit COVID-19 Associated Complications

Corona Virus Infection Clinical Trial

Official title:

Convalescent Plasma To Limit COVID-19 Associated Complications: A Randomized Blinded Phase 2 Study Comparing the Efficacy and Safety of Anti-SARS-CoV-2 Plasma To Placebo in COVID-19 Hospitalized Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04404634
• Other study ID #: 2000028181
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 2020
• Est. completion date: January 2023

Study information

• Verified date: May 2020
• Source: Yale University
• Contact: Mahalia Desruisseaux, MD
• Phone: 203-737-4057
• Email: mahalia.desruisseaux[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, blinded phase 2 trial to assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with a symptom onset between 3 and 7 days OR within 72 hours of hospitalization.

Description:

Yale University is conducting this trial as a single site in collaboration with the New York University protocol. That trial is registered separately in ClinicalTrials.gov (NCT04364737), with Einstein College of medicine listed as a collaborator. Yale has applied for its own IND, which is pending at the time of this registration. Yale will be using the same data capture system and central COVID specific-data safety monitoring board (DSMB) as the other sites.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients =18 years of age

2. Hospitalized with COVID-19 with respiratory symptoms, cough, chest pain, shortness of breath, fever, or oxygen saturation = 94%, or abnormal imaging

3. Hospitalized for less than 72 hours OR within day 3 to 7 days from first signs of illness

4. Laboratory confirmed COVID-19

5. On supplemental oxygen, non-invasive ventilation or high-flow oxygen

6. Patients may be on other randomized controlled trials of pharmaceuticals for COVID

• 19 and patients who meet eligibility criteria will not be excluded on this basis.

Exclusion Criteria:

1. Receipt of pooled immunoglobulin in past 30 days

2. Contraindication to transfusion or history of prior reactions to transfusion blood products

3. Invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)

4. Volume overload secondary to congestive heart failure or renal failure

5. Intracranial bleed

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• Severe Acute Respiratory Syndrome

Intervention

Biological:
• Convalescent Plasma
SARS-CoV-2 convalescent plasma (1-2 units, approximately 250-500 mL) with antibodies to CASR-CoV-2 will be administered.
• Lactated Ringer's Solution or Sterile Saline
Equivalent volume of lactated ringer's solution or sterile saline solution will be administered.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Albert Einstein College of Medicine, NYU Langone Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Status at 14 days	This outcome will be assessed by the World Health Organization (WHO)10-point ordinal scale for clinical improvement: Uninfected 0 Uninfected; no viral RNA detected Ambulatory 1 Asymptomatic; viral RNA detected 2 Symptomatic; Independent 3 Symptomatic; assistance needed Hospitalized: Mild disease 4 Hospitalized; no oxygen therapy 5 Hospitalized; oxygen by mask or nasal prongs Hospitalized: Severe disease 6 Hospitalized; oxygen by NIV or High flow 7 Intubation & Mechanical ventilation 8 Mechanical ventilation 9 Mechanical ventilation and vasopressors, dialysis or extracorporeal membrane oxygenation (ECMO) Death 10 Dead	14 days post-randomization
Secondary	Clinical Status at 28 days	This outcome will be assessed by the World Health Organization (WHO)10-point ordinal scale for clinical improvement: Uninfected 0 Uninfected; no viral RNA detected Ambulatory 1 Asymptomatic; viral RNA detected 2 Symptomatic; Independent 3 Symptomatic; assistance needed Hospitalized: Mild disease 4 Hospitalized; no oxygen therapy 5 Hospitalized; oxygen by mask or nasal prongs Hospitalized: Severe disease 6 Hospitalized; oxygen by NIV or High flow 7 Intubation & Mechanical ventilation 8 Mechanical ventilation 9 Mechanical ventilation and vasopressors, dialysis or extracorporeal membrane oxygenation (ECMO) Death 10 Dead	28 days post-randomization