Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma

Covid-19 Clinical Trial

Official title:

Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04432103
• Other study ID #: ABC-20-14
• Status: Terminated
• Phase: Phase 3
• Start date: August 8, 2020
• Est. completion date: January 29, 2021

Study information

• Verified date: July 2021
• Source: Centro Medico ABC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Open label two arms, non randomized Convalescent Plasma treatment to severe and critical pneumonia COVID-19 hospitlaized patients compared to a historical cohort with matched controls.

Description:

We will perform an open label two arms, non randomized trial giving Convalescent Plasma donated from recovered COVID-19 patients with positive serology to severe and clinical pneumonia COVID-19 patients admitted to the ABC Medical Center.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 29, 2021
• Est. primary completion date: January 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Donors:

1. Age: >18 and <60 years

2. Body weight : >60 kg

3. Confirmed previous SARS CoV-2 infection

4. negative SARS CoV-2 test result

5. 21 day without symptoms from the negative SARS CoV2 negative test

6. Written informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing.

7. Positive COVID-19 IgG antibodies

8. Male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for HLA antibodies

9. Individuals who meet all regular voluntary donor eligibility requirements by the Mexican legislation.

Patients/recipients:

1. Age: >18 years

2. Admitted to the ABC Medical Center facility for the treatment of COVID-19

3. Patients with severe or critical COVID-19

4. Informed consent provided by the patient or healthcare proxy Exclusion Criteria:

Patients/recipients:

1. Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products) 2. Any other not controlled infection 3. Disseminated Intravascular Coagulopathy

4. Patient under dialysis 5. Patient with recent Hemorrhagic Stroke 6. Severe Ischemic Heart Disease -

Related Conditions & MeSH terms

• Covid-19
• Pneumonia

Intervention

Biological:
• Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients
Administration of Convalescent Plasma to COVID-19 obtained from donors with prior documented SARS-CoV 2 infection with IgG antibodies to hospitalized COVID-19 severe cases.
• Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients
Administration of Convalescent Plasma to COVID-19 obtained from donors with prior documented SARS-CoV 2 infection with IgG antibodies to hospitalized COVID-19 critical cases.

Locations

Country	Name	City	State
Mexico	Centro Medico Abc	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Centro Medico ABC

Country where clinical trial is conducted

Mexico, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	INCIDENCE OF CRITICAL PNEUMONIA	progression to critical stage	14 days after convalescent plasma administration
Primary	MORTALITY RATE AMONG CRITICAL PNEUMONIA PATIENTS	mortality	28 days after convalescent plasma administration
Secondary	INCIDENCE OF MECHANICAL VENTILATION	time to need mechanical ventilation	14 days after convalescent plasma treatment
Secondary	DAYS OF MECHANICAL VENTILATION	time of mechanical ventilation needed	28 days after convalescent plasma treatment

External Links

•   CDC. Coronavirus Disease 2019 (COVID-19) [Internet]. Centers for Disease Control and Prevention. 2020 [cited 2020 Apr 7].
•   CDC. Coronavirus Disease 2019 (COVID-19) Situation Summary [Internet]. Centers for Disease Control and Prevention. 2020 [cited 2020 Mar 23].
•   Convalescent Plasma COVID-19 (Coronavirus) Treatment - Mayo Clinic [Internet]. [cited 2020 Apr 8]. Available from:
•   GuíaTransfusión 5a EDICION 2015 [Internet]. [cited 2020 Apr 7].
•   Johns Hopkins Coronavirus Resource Center [Internet]. Johns Hopkins Coronavirus Resource Center. [cited 2020 Mar 23].
•   National COVID-19 Convalescent Plasma Project [Internet]. [cited 2020 Apr 8].
•   Novel Coronavirus (2019-nCoV) situation reports [Internet]. [cited 2020 Mar 23].
•   Situation update worldwide, as of 22 March 2020 [Internet]. European Centre for Disease Prevention and Control. [cited 2020 Mar 23]
•   WHO Director-General's remarks at the media briefing on 2019-nCoV on 11 February 2020 [Internet]. [cited 2020 Mar 23].
•   who-china-joint-mission-on-covid-19-final-report.pdf [Internet]. [cited 2020 Mar 23].