NCT04452812: PROMETEO

Statistical and Epidemiological Study Based on the Use of Convalescent Plasma for the Management of Patients With COVID-19

Status unknown Phase 1, PHASE2 Last updated 7 July 2020

What this trial tests

Phase 1, PHASE2 trial testing Convalescent plasma in COVID-19 Pneumonia in 15 participants. Status unknown.

Timeline

6 July 2020

Primary endpoint
1 March 2021

1 April 2021

Quick facts

Lead sponsor	Universidad Autonoma de Coahuila
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	15
Start date	6 July 2020
Primary completion	1 March 2021
Estimated completion	1 April 2021
Sites	1 location across Mexico

Drugs / interventions tested

• Convalescent plasma — full drug profile →

Conditions studied

• COVID-19 Pneumonia — all drugs for COVID-19 Pneumonia →
• Convalescent Plasma — all drugs for Convalescent Plasma →

Sponsor

Universidad Autonoma de Coahuila

Who can join

18 and older, any sex, with COVID-19 Pneumonia or Convalescent Plasma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The health contingency established against the Severe Acute Respiratory Syndrome associated type 2 Coronavirus (SARS-CoV-2) has promoted a race against the clock for the search on treatment against the disease related with coronavirus (COVID-19). There are no current approved therapeutic options against the virus, although there is a rush for the development of drugs, vaccines and even the passive immunization through plasma from convalescent patients. This passive immunization is made with the administration of antibodies from patients that went through the infectious state of the disease and progress to clinical remission.

SARS-CoV-2, and its predecessor SARS-CoV-1, have great similarities between their genes and proteins; tis allow to hypothesize that the antibodies developed against SARS-CoV1 can recognize the antigens of SARS-CoV-2. In this manner, the transfusion of convalescent plasma to patients with the infection brings the probability on eliminating the infection, in this case SARS-CoV-2. There are evidence of this phenomenon observed in previous pandemics caused by SARS-CoV-1, Influenza AH1N1 and Ebola virus.

The objective of the study is to develop a therapeutic strategy based on the administration of plasma from patients with COVID-19 with clinical remission to patients that are coursing with the infection. The expected results hopes to establish an effective treatment and satisfactory recovery of patients with COVID-19. Also, we expect to describe the respective antibodies related against the SARS-CoV-2 infection.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review.
   Piechotta V, Iannizzi C, Chai KL, Valk SJ, et al · · 2021 · cited 106× · PMID 34013969 · DOI 10.1002/14651858.cd013600.pub4
2. Treatment of COVID-19 with convalescent plasma: lessons from past coronavirus outbreaks.
   Wooding DJ, Bach H. · · 2020 · cited 55× · PMID 32791241 · DOI 10.1016/j.cmi.2020.08.005
3. An updated overview of recent advances, challenges, and clinical considerations of IL-6 signaling blockade in severe coronavirus disease 2019 (COVID-19).
   Elahi R, Karami P, Heidary AH, Esmaeilzadeh A. · · 2022 · cited 33× · PMID 35074571 · DOI 10.1016/j.intimp.2022.108536
4. Convalescent plasma for people with COVID-19: a living systematic review.
   Iannizzi C, Chai KL, Piechotta V, Valk SJ, et al · · 2023 · cited 24× · PMID 36734509 · DOI 10.1002/14651858.cd013600.pub5
5. Convalescent plasma for people with COVID-19: a living systematic review.
   Iannizzi C, Chai KL, Piechotta V, Valk SJ, et al · · 2023 · cited 21× · PMID 37162745 · DOI 10.1002/14651858.cd013600.pub6