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CoronavirusPhase 2/3CP-COVID-19NCT04332835

Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study

A Phase 2/3 study testing Plasma and Standard Therapy in people with Coronavirus and Coronavirus Infection, run by Universidad del Rosario at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Coronavirus, Coronavirus Infection
What is being tested?
Plasma and Standard Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteColombia
Study dates
8 Aug 2020to 15 Nov 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Olerder than 18.
  • Hospitalized participants with diagnosis of COVID 19 by Real Time - Polymerase Chain Reaction.
  • Severe cases according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 7)".
  • Sequential Organ Failure Assessment score (SOFA) < 6.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Female subjects who are pregnant or breastfeeding.
  • Patients with prior allergic reactions to transfusions.
  • Critical ill patients in intensive care units with requierment of Invasive Mechanical Venitlation.
  • Patients with surgical procedures in the last 30 days.
  • Patients with active treatment for cancer (Radiotherapy or Chemotherapy).
  • HIV diagnosed patients with viral failure (detectable viral load> 1000 copies / ml persistent, two consecutive viral load measurements within a 3 month interval, with medication adherence between measurements after at least 6 months of starting a new regimen antiretrovirals).
Show all 12Show fewer
  • Demonstrated coinfection that explains the patient's symptoms
  • End-stage chronic kidney disease (Glomerular Filtration Rate <15 ml / min / 1.73 m2).
  • Child Pugh C stage liver cirrhosis.
  • High cardiac output diseases.
  • Autoimmune diseases or Immunoglobulin A nephropathy.
  • Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.

Trial locations and contacts

1 site in 1 country.

Colombia1 site

  • Universidad del Rosario

    Bogota, Cundinamarca, 11100

Other trials in Colombia

About this study

Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks

Read the detailed description

The process is based on obtaining plasma from patients recovered from COVID-19 in Colombia, and through a donation of plasma from the recovered, the subsequent transfusion of this to patients infected with coronavirus disease (COVID-19). Our group has reviewed the scientific evidence regarding the application of convalescent plasma for emergency viral outbreaks and has recommended the following protocol

Being tested
Plasma, Standard Therapy
Keywords
COVID-19, Coronavirus Disease 2019
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlasmaDrug

    Also called Convalescent Plasma COVID-19

    Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.

  • Standard TherapyDrug

    Standard therapy defined by institutional protocol.

Study groups in NCT04332835
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants included in the experimental group will receive 500 milliliters of convalescent plasma, distributed in two 250 milliliters transfusions on the first and second day after starting the protocol. Simultaneously, they will receive the standard therapy defined by institutional protocol.
Receives: Drug: Plasma; Drug: Standard Therapy
Control GroupActive comparatorParticipants included in the control group will receive standard therapy defined by institutional protocol.
Receives: Drug: Standard Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Viral Load

    Copies of COVID-19 per ml

    Measured: Days 0, 4, 7, 14 and 28

  2. Change in Immunoglobulin G COVID-19 Titers

    Immunoglobulin G COVID-19 antibodies

    Measured: Days 0, 4, 7, 14 and 28

Secondary outcomes (7)

  1. Intensive Care Unit Admission

    Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)

    Measured: Days 7, 14 and 28

  2. Length of Intensive Care Unit stay

    Days of Intensive Care Unit management (days 7, 14 and 28)

    Measured: Days 7, 14 and 28

  3. Length of hospital stay (days)

    Days of Hospitalization (days 7, 14 and 28)

    Measured: Days 7, 14 and 28

  4. Requirement of mechanical ventilation

    Proportion of patients with mechanical ventilation (days 7, 14 and 28)

    Measured: Days 7, 14 and 28

  5. Duration (days) of mechanical ventilation

    Days with mechanical ventilation (days 7, 14 and 28)

    Measured: Days 7, 14 and 28

  6. Clinical status assessed according to the World Health Organization guideline

    1. Hospital discharge; 2. Hospitalization, not requiring supplemental oxygen; 3. Hospitalization, requiring supplemental oxygen (but not Noninvasive Ventilation/ HFNC); 4. Intensive care unit/hospitalization, requiring Noninvasive Ventilation/ HFNC therapy; 5. Intensive care unit, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 6. Death. (days 7, 14 and 28)

    Measured: Days 7, 14 and 28

  7. Mortality

    Proportion of death patients at days 7, 14 and 28

    Measured: Days 7, 14 and 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2020
  2. Study start8 Aug 2020
  3. Primary completion31 Oct 2020
  4. Study completion15 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04332835
Sponsor's protocol ID
ABN011-2
Acronym
CP-COVID-19
Status last verified
Nov 2020
First submitted
31 Mar 2020
Last updated
27 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

    PubMed 31986264

  • Wang Y, Wang Y, Chen Y, Qin Q. Unique epidemiological and clinical features of the emerging 2019 novel coronavirus pneumonia (COVID-19) implicate special control measures. J Med Virol. 2020 Jun;92(6):568-576. doi: 10.1002/jmv.25748. Epub 2020 Mar 29.

    PubMed 32134116

  • Young BE, Ong SWX, Kalimuddin S, Low JG, Tan SY, Loh J, Ng OT, Marimuthu K, Ang LW, Mak TM, Lau SK, Anderson DE, Chan KS, Tan TY, Ng TY, Cui L, Said Z, Kurupatham L, Chen MI, Chan M, Vasoo S, Wang LF, Tan BH, Lin RTP, Lee VJM, Leo YS, Lye DC; Singapore 2019 Novel Coronavirus Outbreak Research Team. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. 2020 Apr 21;323(15):1488-1494. doi: 10.1001/jama.2020.3204.

    PubMed 32125362

  • Infectious, D. & Outbreaks, D. Maintaining a safe and adequate blood supply during the pandemic outbreak of coronavirus disease ( COVID-19 ). OMS 1-5 (2020)

  • Rojas M, Rodriguez Y, Hernandez JC, Diaz-Coronado JC, Vergara JAD, Velez VP, Mancilla JP, Araujo I, Yepes JT, Ricaurte OB, Pardo-Oviedo JM, Monsalve DM, Acosta-Ampudia Y, Ramirez-Santana C, Garcia PG, Landinez LA, Correales LD, Grass JS, Perez CR, Lopez GS, Mateus N, Mancera L, Devia RR, Orjuela JE, Parra-Moreno CR, Buitrago AA, Ordonez IE, Osorio CF, Ballesteros N, Patino LH, Castaneda S, Munoz M, Ramirez JD, Bastard P, Gervais A, Bizien L, Casanova JL, Camacho B, Gallo JE, Gomez O, Rojas-Villarraga A, Perez CE, Manrique R, Mantilla RD, Anaya JM. Safety and efficacy of convalescent plasma for severe COVID-19: a randomized, single blinded, parallel, controlled clinical study. BMC Infect Dis. 2022 Jun 27;22(1):575. doi: 10.1186/s12879-022-07560-7.

    PubMed 35761219

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Plasma and Standard Therapy in people with Coronavirus and Coronavirus Infection, run by Universidad del Rosario at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Viral Load (time frame: Days 0, 4, 7, 14 and 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04332835, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.

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CP-COVID-19 Clinical Trial NCT04332835 | AzTrials