Clinical trial to evaluate superiority of anti-SARS-CoV-2 convalescent plasma versus standard-of-care in hospitalized patients with mild COVID-19

Phase 1

• Conditions: Hospitalized patients with mild SARS-CoV-2 infection (WHO R&D Blueprint Ordinal Scale for Clinical Improvement = 3 or 4); MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001936-86-DE
• Lead Sponsor: Hannover Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-20
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

Patients infected with SARS-CoV-2 virus and
1.age = 18 years and = 75 years
2.fulfills RKI case definition including a positive verification of a SARS-CoV-2 infection from any specimen (e.g. respiratory, blood, other bodily fluid)*
* confirmed by PCR (BAL, sputum, nasal and/or pharyngeal swap)
3.mild disease defined by the following criteria:
- Hospitalized (score 3 or 4 of WHO R&D Blueprint ordinal scale for clinical improvement)
4.signed written informed consent and willingness to comply with treatment and follow-up procedures
5.
? men;
or
? women without childbearing potential defined as follows:
•at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy,
•hysterectomy or uterine agenesis,
•= 50 years and in postmenopausal state > 1 year, or
•< 50 years and in postmenopausal state > 1 year with serum FSH > 40 IU/l and serum estrogen < 30 ng/l or a negative estrogen test, both at screening;
or
? women with childbearing potential:
•who are practicing true abstinence from sexual intercourse (periodic abstinence and withdrawal are not acceptable),
•who have sexual relationship with female partners only and/or with sterile male partners, or
•who are sexually active with fertile male partner, have a negative pregnancy test during screening and agree to use reliable methods of contraception from the time of screening until end of the clinical trial.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

1.Accompanying diseases other than COVID-19 with an expected survival time of less than 12 months
2.In the opinion of the clinical team, progression to death is imminent and inevitable with-in the next 24 hours, irrespective of the provision of treatment
3.Chronic obstructive lung disease (COPD), stage 4
4.Lung fibrosis with UIP pattern in CT und severe emphysema
5.Chronic heart failure NYHA >= 3 and/or pre-existing reduction of left ventricular ejection fraction to = 30%
6.Liver cirrhosis Child C
7.Liver failure: Bilirubin > 5xULN and elevation of ALT /AST (at least one >10xULN).
8.End stage renal failure requiring hemodialysis
9.Organ or bone marrow transplant in the three month prior to screening
10.History of adverse reactions to plasma proteins
11.Known deficiency of immunoglobulin A
12.Pregnancy and breastfeeding women
13.Volume overload until sufficiently treated
14.Pulmonary edema
15.Body mass index (BMI) > 40 kg/m2
16.Participation in another clinical trial, especially for treatment of COVID-19
17.Allergy or other contraindication to one of the investigational products
18.Previous treatment with SARS-CoV-2 convalescent plasma

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of convalescent plasma for the treatment of hospitalized patients with mild COVID-19 infection;Secondary Objective: To evaluate the safety and tolerability of experimental regimen;Primary end point(s): Proportion of patients with treatment failure on day 14. A treatment failure is defined as pro-gression of COVID-19 disease. Progression is defined as score 5, 6, 7 or 8 of WHO R&D Blueprint ordinal scale for clinical improvement.;Timepoint(s) of evaluation of this end point: Day 14