Standard or Convalescent Plasma in Patients With Recent Onset of COVID-19 Respiratory Failure

NCT04428021 | Completed Phase 2 DMC

• 1 other identifier: CS3/33
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

To date no specific treatment has been proven to be effective for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2) infection. It is possible that convalescent plasma that contains antibodies to SARS-Cov-2 might be effective against the progression of infection. Promising results have been shown by preliminary data from China cases. The investigators planned to compare effectiveness of adding COVID-19 convalescent plasma to standard therapy protocol (STP) versus adding plasma donated in pre-COVID era versus STP alone in patient with COVID-19 within 5 days from the onset of respiratory distress. STP at enrolment is the best evidence based therapy approved for treatment of COVID patients by regional Health system emergency committee.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 30-days survival

  Proportion of patients alive 30 days after randomization

  30 days after randomization

Secondary Outcomes (8)

• Ventilator free survival

  30 days after randomization

• 6-months survival

  6 months after randomization

• Incidence of complications

  Within 12 months

• Days in intensive care units (ICU)

  From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 12 months

• Positivity for Immunoglobulin G to SARS-Cov-2

  On day 0, 2, 4, 6,10,14, 21, 28 after randomization and at date of discharge or death from any cause, whichever came first, assessed up to 12 months

Study Arms (3)

Standard therapy protocol (STP)

ACTIVE COMPARATOR

STP is defined as the best evidence based therapy approved for treatment of COVID-19 patients by Regional Health System emergency committee. STP could be updated during the trial.

Drug: Standard Therapy Protocol (STP)

STP + Standard Plasma (SP)

EXPERIMENTAL

STP + 3 units on day 1-3-5 of Standard Plasma collected in pre-COVID era (January-September 2019)

Drug: Standard Therapy Protocol (STP); Other: STP + Standard Plasma (SP)

STP + COVID-19 Convalescent Plasma (CP)

EXPERIMENTAL

STP + 3 units on day 1-3-5 of COVID-19 Convalescent Plasma containing neutralizing SARS-Cov-2 antibodies

Drug: Standard Therapy Protocol (STP); Other: STP + COVID-19 Convalescent Plasma (CP)

Interventions

Standard Therapy Protocol (STP) DRUG

Standard Therapy Protocol according to the best evidence treatment recommended by the Regional Health System emergency committee

STP + COVID-19 Convalescent Plasma (CP); STP + Standard Plasma (SP); Standard therapy protocol (STP)

STP + Standard Plasma (SP) OTHER

Transfusion of three Standard Plasma Units (SP) on day 1,3,5 in addition to STP

STP + Standard Plasma (SP)

STP + COVID-19 Convalescent Plasma (CP) OTHER

Transfusion of three SARS-Cov-2 neutralizing antibodies positive Plasma Units (CP) on day 1,3,5 in addition to STP

STP + COVID-19 Convalescent Plasma (CP)

Eligibility Criteria

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

You may qualify if:

• Confirmed SARS-Cov-2 diagnosis by RT-PCR on nasopharyngeal swab or on bronchoalveolar lavage
• Respiratory failure onset or progression within 5 days
• Signed Informed Consent

You may not qualify if:

• Pregnancy
• Previous severe reactions to plasma transfusion
• Unavailability of blood group compatible COVID-19 convalescent plasma

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead

Study Sites (1)

AO Città della salute e della scienza di Torino

Torino, 10126, Italy

Location

Related Publications (1)

• Manzini PM, Ciccone G, De Rosa FG, Cavallo R, Ghisetti V, D'Antico S, Galassi C, Saccona F, Castiglione A, Birocco N, Francisci T, Hu H, Pecoraro C, Danielle F, Labanca L, Bordiga AM, Lorenzi M, Camisasca G, Giachino O, Pagliarino M, Ottone P, Scuvera ITD, Guaschino R, Freilone R, Berti P, Pittaluga F, Avolio M, Costa C, Raso S, Nucci A, Milan M, Baffa A, Russo A, Tornello A, Maddalena L, Delios G, Marletto FP, De Micheli AG, Mattei A, Baldassano S, Canta F, Russo ML, Bergamo D, Vitale F, Liccardi MM, Chinaglia A, Calcagno A, Converso M, Aldieri C, Libanore V, Blangetti I, Benedetti V, Mitola B, Scozzari G; PLACO COVID Study Group. Convalescent or standard plasma versus standard of care in the treatment of COVID-19 patients with respiratory impairment: short and long-term effects. A three-arm randomized controlled clinical trial. BMC Infect Dis. 2022 Nov 22;22(1):879. doi: 10.1186/s12879-022-07716-5.

  PMID: 36418984 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

• Paola Maria Manzini, MD

  AO Città della salute e della scienza di Torino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Only the two experimental arms are masked. COVID-19 convalescent plasma (CP) and standard plasma (SP) will be masked and delivered to the wards in identical bags; a tag printed as "PLASMA TRIAL" will cover the actual name of the product
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three arms randomized trial, partially blinded

Study Record Dates

• First Submitted: June 7, 2020
• First Posted: June 11, 2020
• Study Start: June 15, 2020
• Primary Completion: March 31, 2021
• Study Completion: October 31, 2021
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available after 12 months from study ending and for the following 5 years
• Access Criteria: Data requests should be submitted to the corresponding author for consideration.

Locations

IT (1)