CP-COVID-19: Convalescent Plasma for Patients With COVID-19: A Pilot Study

• Sponsor: Universidad del Rosario (Other)
• Overall Status: Completed
• CT.gov ID: NCT04332380
• Collaborator: CES University (Other), Instituto Distrital de Ciencia Biotecnologia e Innovacion en salud (Other), Fundación Universitaria de Ciencias de la Salud (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.9
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus; Coronavirus Infection	Drug: Plasma	Phase 2

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Convalescent Plasma for Patients With COVID-19: A Pilot Study
• Actual Study Start Date: May 1, 2020
• Actual Primary Completion Date: Jul 28, 2020
• Actual Study Completion Date: Jul 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group Participants 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.	Drug: Plasma; Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.; Other Names: Convalescent Plasma COVID-19

Outcome Measures

Primary Outcome Measures

1. Change in Viral Load [Days 0, 4, 7, 14 and 28]

   Copies of COVID-19 per ml

2. Change in Immunoglobulin M COVID-19 antibodies Titers [Days 0, 4, 7, 14 and 28]

   Immunoglobulin M COVID-19 antibodies

3. Change in Immunoglobulin G COVID-19 antibodies Titers [Days 0, 4, 7, 14 and 28]

   Immunoglobulin G COVID-19 antibodies

Secondary Outcome Measures

1. Intensive Care Unit Admission [Days 7, 14 and 28]

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

2. Length of Intensive Care Unit stay [Days 7, 14 and 28]

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

3. Length of hospital stay (days) [Days 7, 14 and 28]

   Days of Hospitalization (days 7, 14 and 28)

4. Requirement of mechanical ventilation [Days 7, 14 and 28]

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

5. Duration (days) of mechanical ventilation [Days 7, 14 and 28]

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

6. Clinical status assessed according to the World Health Organization guideline [Days 7, 14 and 28]

   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)

7. Mortality [Days 7, 14 and 28]

   Proportión of death patients at days 7, 14 and 28

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:Fulfilling all the following criteria

1. Aged between 18 and 60 years, male or female.

2. Hospitalized participants with diagnosis for COVID 19 by Real Time - Polymerase Chain Reaction.

3. Without treatment.

4. Moderate cases according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)".

5. Confusion, Urea, Respiratory rate, Blood pressure-65 (CURB-65) >= 2.

6. Sequential Organ Failure Assessment score (SOFA) < 6.

7. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding.

2. Patients with prior allergic reactions to transfusions.

3. Critical ill patients in intensive care units.

4. Patients with surgical procedures in the last 30 days.

5. Patients with active treatment for cancer (Radiotherapy or Chemotherapy).

6. 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).

7. Patients who have suspicion or evidence of coinfections.

8. End-stage chronic kidney disease (Glomerular Filtration Rate <15 ml / min / 1.73 m2).

9. Child Pugh C stage liver cirrhosis.

10. High cardiac output diseases.

11. Autoimmune diseases or Immunoglobulin A nephropathy.

12. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad del Rosario	Bogota	Cundinamarca	Colombia	11100

Sponsors and Collaborators

• Universidad del Rosario
• CES University
• Instituto Distrital de Ciencia Biotecnologia e Innovacion en salud
• Fundación Universitaria de Ciencias de la Salud

Investigators

• Principal Investigator: Juan M Anaya Cabrera, MD, PhD, Universidad del Rosario

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• FDA recommendations for convalescent plasma clinical research

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. Erratum in: Lancet. 2020 Jan 30;:.
• Infectious, D. & Outbreaks, D. Maintaining a safe and adequate blood supply during the pandemic outbreak of coronavirus disease ( COVID-19 ). OMS 1-5 (2020).
• 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. Review.
• 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. Erratum in: JAMA. 2020 Apr 21;323(15):1510.

• Responsible Party: Juan Manuel Anaya Cabrera, MD, PhD, Principal Investigator, Universidad del Rosario
• ClinicalTrials.gov Identifier: NCT04332380
• Other Study ID Numbers: ABN011-1
• First Posted: Apr 2, 2020
• Last Update Posted: Aug 17, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Juan Manuel Anaya Cabrera, MD, PhD, Principal Investigator, Universidad del Rosario: COVID-19; Coronavirus Disease 2019
• Additional relevant MeSH terms: COVID-19; Coronavirus Infections

Study Results

No Results Posted as of Aug 17, 2020