Convalescent Plasma Therapy - Zurich Protocol

NCT04869072 | Completed Phase 1 DMC

• 1 other identifier: 2020-00787
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single-center, phase I study to assess the safety and efficacy of convalescent plasma therapy (CPT) obtained from donors who were tested positive for SARS-CoV-2 and fully recovered from the infection and administered to patients who are infected with the new coronavirus and present dyspnea or a poor prognosis

Conditions

COVID-19

Outcome Measures

Primary Outcomes (11)

• Safety of CPT applied to COVID-19 patients

  Absence of clinical signs of Transfusion Related Lung Inflammation (TRALI) and/or allergic reactions and/or Transfusion Associated Circulatory Overload (TACO)

  clinical observation up to 48 hours after the last dose of plasma

• Safety of CPT applied to COVID-19 patients

  Absence of laboratory signs of haemolytic reactions

  1 week (laboratory monitoring up to 7 days after the last administration of plasma)

• Improvement of respiratory frequency

  Respiratory frequency will be measured at each study visit

  3 weeks after the last administration of plasma

• Improvement of O2-saturation

  O2-Saturation will be measured at each study visit

  3 weeks after the last administration of plasma

• Improvement of Inflammatory markers (C Reactive Protein, CRP)

  CRP will be measured at each study visit

  3 weeks after the last administration of plasma

• Improvement of Inflammatory markers (Ferritin)

  Ferritin will be measured at each study visit

  3 weeks after the last administration of plasma

• Improvement of Inflammatory markers (IL-6)

  IL-6 will be measured at each study visit

  3 weeks after the last administration of plasma

• Improvement of coagulation-markers (D-dimer)

  D-Dimer will be measured at each study visit

  3 weeks after the last administration of plasma

• Improvement of coagulation-markers (Fibrinogen)

  Fibrinogen will be measured at each study visit

  3 weeks after the last administration of plasma

• Improvement of coagulation-markers (LDH)

  LDH will be measured at each study visit

  3 weeks after the last administration of plasma

• Prevention of ICU-admission

  clinical conditions will be assessed throughout the study

  3 weeks after the last administration of plasma

Secondary Outcomes (3)

• Characterisation of virus reaction to plasma Therapy

  10 Weeks

• Characterisation of the dynamic of humoral response after therapy

  10 Weeks

• Better characterize the the in-vivo anti-virus humoral response against SARS-CoV-2.

  10 Weeks

Interventions

Convalescent plasma DRUG

Convalescent plasma will be delivered as FFP. Three units of 200ml CP/FFP harvested from one donor will be transfused to one recipient, i.e. there will be a match between donor and recipient and each recipient will receive CP/FFP only from one donor. CP/FFP will be administered intravenously at the infusion rate of 100ml/hour, starting from day 0, with a new transfusion every 24 hours, for a total of 3 transfusions (see scheme).

Also known as: Fresh Frozen Plasma (FFP)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A) Proven Sars-CoV-2 by PCR and hospitalization for COVID-19 in combination with either (1) or (2):
• Age ≥50
• AND (at least one):
• Pre-existing cardiovascular disease
• Diabetic disease
• Immunodeficiency/immunosuppression
• Neoplastic disease
• COPD or chronic liver disease or chronic renal failure
• Age ≥18
• AND (at least one):
• SpO2 ≤ 94% on room air or requiring supplemental oxygen at screening
• Typical changes on chest x-ray and/or lung-CT scan
• Immunosuppression or neoplastic disease
• B) Informed Consent as documented by signature (Appendix Informed Consent Form) of the patient or, in case of inability, of the next relative/care-taking person. In the latter case, an independent doctor will also be involved and her/his signature will be required in order to enrol the patient.

You may not qualify if:

• Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product (FFP)
• Known IgA deficiency
• Cytokine Release Syndrome grade ≥3 (see score)\*
• ARDS
• Patients already hospitalized in intensive care unit and/or already receiving mechanical ventilation
• Known or suspected non-compliance, drug or alcohol abuse
• Previous enrolment into the current study
• Enrolment of the investigator, his/her family members, employees and other dependent persons
• Women who are pregnant or breast feeding
• Intention to become pregnant during the course of the study
• Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Marconato M, Abela IA, Hauser A, Schwarzmuller M, Katzensteiner R, Braun DL, Epp S, Audige A, Weber J, Rusert P, Schindler E, Pasin C, West E, Boni J, Kufner V, Huber M, Zaheri M, Schmutz S, Frey BM, Kouyos RD, Gunthard HF, Manz MG, Trkola A. Antibodies from convalescent plasma promote SARS-CoV-2 clearance in individuals with and without endogenous antibody response. J Clin Invest. 2022 Jun 15;132(12):e158190. doi: 10.1172/JCI158190.

  PMID: 35482408 DERIVED

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

• Markus Manz, Professor

  University of Zurich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open-label, single-center, phase I study to assess the safety and efficacy of convalescent plasma therapy (CPT).

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: May 3, 2021
• Study Start: April 29, 2020
• Primary Completion: November 30, 2020
• Study Completion: March 30, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)