AzTrials
AzTrials

COVID-19 InfectionPhase 2/3FALP-COVIDNCT04384588

COVID19-Convalescent Plasma for Treating Patients With Active Symptomatic COVID 19 Infection (FALP-COVID)

A Phase 2/3 study testing Convalescent Plasma from COVID-19 donors in people with COVID-19 Infection and Cancer Patients, run by Fundacion Arturo Lopez Perez at 1 site in Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

COVID-19 infection has spread worldwide causing several deaths in few months Convalescent Plasma from COVID 19 donors has shown huge activity in small series from Chinese patients and currently many centers from USA and the European Union are assessing its use looking to avoid mortality and prolonged hospitalizations… Read more about this study

Who is it for?
Ages 15 years and older
What is being tested?
Convalescent Plasma from COVID-19 donors
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChile
Study dates
7 Apr 2020to 6 Apr 2021
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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • For all patients:
  • Patient must sign an informed consent to participate in this trial
  • Signed consent to participate in this trial must be given not after 14 days from the first day of symptoms COVID-19 related
  • Patients with severity criteria must have any of the following: dyspnea and or respiratory rate >=30 per min and or saturation <= 93% with fraction of inspired oxygen 21% and or ratio of partial pressure arterial oxygen and fraction of inspired oxygen (PaFi )<300 and or lung images showing worsening in 24-48 hours
  • or
  • Patients without severity criteria but with 2 or more factor risks:
Show all 14Show fewer
  • 50 years or older
  • any of the following comorbidities: Diabetes Mellitus, Hypertension, Chronic Obstructive Pulmonary Disease, Chronic Kidney Failure, non-oncological related chronic immunosuppression
  • Total bilirubin>1,2 mg/dl or Blood Urea Nitrogen> 20 mg/dl or Lactate Dehydrogenase>245 U/L
  • D-dimer > 1mg/L
  • Neutrophils 7.3 x 10³ or greater and or Lymphocytes lesser than 0,8 x 10³ µl
  • C reactive protein >9,5 mg/dl and ferritin > 300 ug/ml
  • Interleukin-6 >7 pg/mL
  • antineoplastic treatment such as radiotherapy- cytotoxic chemotherapy- immunotherapy- molecular therapy- oncological surgery during the last 8 weeks

Who cannot join

  • known allergy to plasma
  • Severe multiple organic failure
  • Active intra brain hemorrhage
  • Disseminated intravascular coagulation with blood products requirements
  • Patient with an adult respiratory distress longer than 10 days
  • patients with active cancer and life expectancy shorter than 12 months according with medical criteria

Trial locations and contacts

1 site in 1 country.

Christian Caglevic, MD contact

56981369487

christian.caglevic@falp.org

Chile1 site, 1 recruiting

  • Fundacion Arturo Lopez Perez

    Providencia, Santiago Metropolitan, 7500921

    Christian Caglevic, md, christian.caglevic@falp.org

    Recruiting

Other trials in Chile

About this study

Official title: Investigational- Compassionate Use of Convalescent Plasma From COVID-19 Donors in Oncological and Non-Oncological Patients With Severity Criteria: FALP 001-2020 Trial (FALP-COVID)

COVID-19 infection has spread worldwide causing several deaths in few months Convalescent Plasma from COVID 19 donors has shown huge activity in small series from Chinese patients and currently many centers from USA and the European Union are assessing its use looking to avoid mortality and prolonged hospitalizations COVID-19-related

Read the detailed description

This is a collaborative, 4 arms , non randomized clinical trial assessing the use of Convalescent Plasma from COVID-19 recovered donors to be used in oncological and non-oncological patients with current severe COVID-19 infection or in patients with risk factors of major complications secondary to COVID-19 infection

Being tested
Convalescent Plasma from COVID-19 donors
Keywords
convalescent plasma, COVID
Medical subject headings
COVID-19

What participants receive

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

  • Convalescent Plasma from COVID-19 donorsBiological

    Patients that will participate in this clinical trial will be treated with Convalescent Plasma from COVID-19 donors regardless of the arm where they will be included

Study groups in NCT04384588
Study groupRoleWhat they receive
Cancer patients with COVID 19 infection and severity criteriaExperimentalAll patients will be treated with 1 or more convalescent plasma units
Receives: Biological: Convalescent Plasma from COVID-19 donors
Cancer patients with COVID 19 infection and risk factorsExperimentalAll patients will be treated with 1 or more convalescent plasma units
Receives: Biological: Convalescent Plasma from COVID-19 donors
Non-Cancer patients COVID 19 infection and severity criteriaExperimentalAll patients will be treated with 1 or more convalescent plasma units
Receives: Biological: Convalescent Plasma from COVID-19 donors
Non-cancer patients COVID 19 (+) and risk factorsExperimentalAll patients will be treated with 1 or more convalescent plasma units
Receives: Biological: Convalescent Plasma from COVID-19 donors

What is being measured

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

  1. in-hospital mortality secondary to COVID-19 among patients treated with convalescent plasma

    in-hospital mortality secondary to COVID-19 among patients treated with convalescent plasma

    Measured: 1 year

  2. safety of the use of convalescent plasma drom COVID 19 donors

    safety of convalescent plasma from COVID 19 donors (CTCAE V5.0)

    Measured: 1 year

Secondary outcomes (31)

  1. Mortality at 30 days, 90 days, 6 months and 1 year

    any cause of mortality during these periods

    Measured: 1 year

  2. in-hospital Mortality COVID-19 related compared with non-treated population according to Chilean official reports

    based on results from this trial comparing with official information

    Measured: through study completion, an average of 1 year

  3. Number of days of hospitalization in high complexity facilities after convalescent plasma use

    number of days of hospitalization in high complexity facilities after convalescent plasma use

    Measured: 1 year

  4. Number of days of hospitalization in intensive care unit after convalescent plasma use

    number of days of hospitalization in intensive care unit after convalescent plasma use

    Measured: 1 year

  5. Number of days of mechanical ventilatory support in patients after convalescent plasma use

    number of days of mechanical ventilatory support in patients after convalescent plasma use

    Measured: 1 year

  6. Total number of days of mechanical ventilatory support

    total number of days of mechanical ventilatory support

    Measured: 1 year

  7. Total number of hospitalization days in patients treated with convalescent plasma

    total number of hospitalization days in patients treated with convalescent plasma

    Measured: 1 year

  8. Number of hospitalization days in patients after treatment with convalescent plasma

    total number of hospitalization days in patients after treatment with convalescent plasma

    Measured: 1 year

  9. Viral load measuring

    Viral load measuring

    Measured: 14 days

  10. Immunological response in treated patients (COVID19-Immunoglobulin M and Immunoglobulin G, neutralizing antibodies)

    COVID19-Immunoglobulin M and Immunoglobulin G, neutralizing antibodies

    Measured: day 1 of hospitalization

  11. Negativization of COVID 19 load since convalescent plasma use

    negativization of COVID 19 load since convalescent plasma use

    Measured: 14 days

  12. Negativization of COVID 19 load since hospitalization

    negativization of COVID 19 load since hospitalization

    Measured: 14 days

  13. Negativization of COVID 19 load since first reported symptoms COVID-19 related

    negativization of COVID 19 load since first reported symptoms COVID-19 related

    Measured: 14 days

  14. Donor Interferon Gamma profile characterization

    Interferon Gamma measurement from donor

    Measured: 1 day

  15. Donor Granulocyte Macrophage Colony Stimulating Factor characterization

    Granulocyte Macrophage Colony Stimulating Factor measurement from donor

    Measured: 1 day

  16. Donor Tumor Necrosis Factor Alfa characterization

    Tumor Necrosis Factor Alfa measurement from donor

    Measured: 1 day

  17. Donor Interleukin -1 beta characterization

    Interleukin -1 beta measurement from donor

    Measured: 1 day

  18. Donor Interleukin-2 characterization

    Interleukin -2 measurement from donor

    Measured: 1 day

  19. Donor Interleukin-4 characterization

    Interleukin -4 measurement from donor

    Measured: 1 day

  20. Donor Interleukin-6 characterization

    Interleukin -6 measurement from donor

    Measured: 1 day

  21. Donor Interleukin-8 characterization

    Interleukin -8 measurement from donor

    Measured: 1 day

  22. Donor Interleukin-10 characterization

    Interleukin -10 measurement from donor

    Measured: 1 day

  23. Receptor Interferon Gamma profile characterization

    Interferon Gamma measurement from receptor

    Measured: 1 day

  24. Receptor Granulocyte Macrophage Colony Stimulating Factor characterization

    Granulocyte Macrophage Colony Stimulating Factor measurement from receptor

    Measured: 1 day

  25. receptor Tumor Necrosis Factor Alfa characterization

    Tumor Necrosis Factor Alfa measurement from receptor

    Measured: 1 day

  26. receptor Interleukin -1 beta characterization

    Interleukin -1 beta measurement from receptor

    Measured: 1 day

  27. Receptor Interleukin-2 characterization

    Interleukin -2 measurement from receptor

    Measured: 1 day

  28. Receptor Interleukin-4 characterization

    Interleukin -4 measurement from receptor

    Measured: 1 day

  29. Receptor Interleukin-6 characterization

    Interleukin -6 measurement from receptor

    Measured: 1 day

  30. Receptor Interleukin-8 characterization

    Interleukin -8 measurement from receptor

    Measured: 1 day

  31. Receptor Interleukin-10 characterization

    Interleukin -10 measurement from receptor

    Measured: 1 day

Timeline

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

  1. First posted12 May 2020
  2. Study start7 Apr 2020
  3. Primary completion6 Apr 2021 (estimated)
  4. Study completion6 Apr 2021 (estimated)

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
Non-randomised
Intervention model
Parallel groups
Model description
Multicenter, non-randomized, 4 arms
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04384588
Sponsor's protocol ID
FALP 001-2020
Acronym
FALP-COVID
Status last verified
May 2020
First submitted
29 Apr 2020
Last updated
12 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Convalescent Plasma from COVID-19 donors in people with COVID-19 Infection and Cancer Patients, run by Fundacion Arturo Lopez Perez at 1 site in Chile.

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 14 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 May 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 Chile. 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?

Results are not available in the source record.

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

Contact Christian Caglevic, MD (56981369487, christian.caglevic@falp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

in-hospital mortality secondary to COVID-19 among patients treated with convalescent plasma (time frame: 1 year). 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 NCT04384588.

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 12 May 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in