Convalescent Plasma Therapy for COVID-19 Patients

NCT04565197 | Unknown Early Phase 1 DMC

• 1 other identifier: LGH008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Passive immunization involves the administration of antibodies against a given agent to a susceptible individual for the purpose of preventing or treating an infectious disease due to that agent. A general principle of passive antibody therapy is that it is more effective when used for prophylaxis than for treatment of disease. When used for therapy, antibody is most effective when administered shortly after the onset of symptoms

Conditions

SARS-CoV Infection

Keywords

COVID-19, Convalescent plasma therapy

Outcome Measures

Primary Outcomes (1)

• clinical outcome after plasma therapy

  Clinical Improvement of COVID-19 patients by giving them passive immunization

  10 days

Secondary Outcomes (1)

• Clinical response to treatment

  10 days

Study Arms (1)

Group intervene with convalescent plasma

EXPERIMENTAL

Review effect of Plasma therapy as clinical trial among hospitalized patients with COVID-19 infection. Transfuse 2 aliquots of plasma (200 mL x 2) per patient. * Transfuse first aliquot for 2-3 hours (\~1.4 to 2 mL/min) * Transfuse second aliquot at same rate 2 hours after completion of first aliquot

Biological: convalescent plasma

Interventions

convalescent plasma BIOLOGICAL

Transfuse 2 aliquots of plasma (200 mL x 2) per patient. * Transfuse first aliquot for 2-3 hours (\~1.4 to 2 mL/min) * Transfuse second aliquot at same rate 2 hours after completion of first aliquot

Also known as: Plasma therapy

Group intervene with convalescent plasma

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe or critically ill COVID-19 patients tested positive in respiratory tract test.
• The COVID-19 patients who are not severe or critically ill, but in a state of immunity suppression;
• or have low CT values in the virus nucleic acid testing but with a rapid disease progression in the lungs.
• Severe or immediately life-threatening COVID-19, for example,
• Severe disease is defined as one or more of the following:
• shortness of breath (dyspnea),
• respiratory frequency ≥ 30/min,
• blood oxygen saturation ≤ 93%,
• partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300,
• lung infiltrates \> 50% within 24 to 48 hours
• Within 3 to 21 days from onset of symptoms

You may not qualify if:

• Life-threatening disease is defined as one or more of the following: respiratory failure, septic shock, multiple organ dysfunction or failure
• Critically ill COVID-19 patients will not considered suitable for being transfusion as inflammatory pathway is already set in, so antibodies will not make that much of difference.

Sponsors & Collaborators

• Lahore General Hospital: lead

Study Sites (1)

Muhammad Irfan Malik

Lahore, Punjab Province, 54500, Pakistan

Location

Related Publications (6)

• Robbins JB, Schneerson R, Szu SC. Perspective: hypothesis: serum IgG antibody is sufficient to confer protection against infectious diseases by inactivating the inoculum. J Infect Dis. 1995 Jun;171(6):1387-98. doi: 10.1093/infdis/171.6.1387.

  PMID: 7769272 BACKGROUND

• Casadevall A, Scharff MD. Serum therapy revisited: animal models of infection and development of passive antibody therapy. Antimicrob Agents Chemother. 1994 Aug;38(8):1695-702. doi: 10.1128/AAC.38.8.1695. No abstract available.

  PMID: 7985997 BACKGROUND

• Garraud O. Use of convalescent plasma in Ebola virus infection. Transfus Apher Sci. 2017 Feb;56(1):31-34. doi: 10.1016/j.transci.2016.12.014. Epub 2016 Dec 30.

  PMID: 28094110 BACKGROUND

• Luke TC, Casadevall A, Watowich SJ, Hoffman SL, Beigel JH, Burgess TH. Hark back: passive immunotherapy for influenza and other serious infections. Crit Care Med. 2010 Apr;38(4 Suppl):e66-73. doi: 10.1097/CCM.0b013e3181d44c1e.

  PMID: 20154602 BACKGROUND

• Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.

  PMID: 21248066 BACKGROUND

• Balabolkin MI. [Various problems of thyroidology]. Ter Arkh. 1988;60(9):136-41. No abstract available. Russian.

  PMID: 3217871 BACKGROUND

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19

Interventions

Immunization, Passive

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Intervention Hierarchy (Ancestors)

Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Muhammad Irfan Malik, FCPS

  Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Qausi-experimental

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 25, 2020
• Study Start: May 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-12

Locations

PA (1)