SARS-CoV InfectionEarly Phase 1NCT04565197
Convalescent Plasma Therapy for COVID-19 Patients
A Early Phase 1 study testing convalescent plasma in people with SARS-CoV Infection, run by Lahore General Hospital at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- SARS-CoV Infection
- What is being tested?
- convalescent plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2020to 30 Dec 2020
- Phase
- Early Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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),
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Convalescent Plasma for Passive Immunization in COVID-19 ICU Patients: An Interventional Study
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
Read the detailed description
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. The reason for temporal variation in efficacy is not well understood but could reflect that passive antibody works by neutralizing the initial inoculums, which is likely to be much smaller than that of established disease . As an example, passive antibody therapy for pneumococcal pneumonia was most effective when administered shortly after the onset of symptoms, and there was no benefit if antibody administration was delayed past the third day of disease.
Therapeutic and prophylactic significance was explored in influenza and measles . Transfusion of immune plasma is a standard treatment modality for various viral hemorrhagic fevers . Its efficacy in treating Ebola Virus Disease is also well established . Studies have reported reduction viral load in patients with H1N1 influenza .Efficacy of convalescent plasma has been anecdotally reported in SARS-CoV-2 infections .
The largest study involved the treatment of 80 patients with SARS in Hong Kong. Patients treated before day 14 had improved prognosis defined by discharge from hospital before day 22, consistent with the notion that earlier administration is more likely to be effective .
In the case of SARS-CoV-2, the anticipated mechanism of action by which passive antibody therapy mediated protection is viral neutralization. However, other mechanisms may be possible, such as antibody-dependent cellular cytotoxicity and/or phagocytosis. The only antibody type that is currently available for immediate use SARS-CoV-2 is that found in human convalescent sera.
In China for SARS-CoV-2 disease, it has been found that the convalescent plasma therapy is effective for patients with a disease course exceeding three weeks and whose virus nucleic acid tests continuously to show positive from respiratory tracts specimen. It can speed up virus clearance, increase the numbers of the plasma lymphocytes and NK cells, reduce the level of plasma lactic acid, and improve renal functions.
- Conditions
- SARS-CoV Infection
- Being tested
- convalescent plasma
- Keywords
- COVID-19, Convalescent plasma therapy
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
convalescent plasmaBiological
Also called Plasma therapy
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: convalescent plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical outcome after plasma therapy
Clinical Improvement of COVID-19 patients by giving them passive immunization
Measured: 10 days
Secondary outcomes (1)
Clinical response to treatment
Overall survival of COVID-19 patients after plasma administration.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 May 2020
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Qausi-experimental
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. M.Irfan Malik, Lahore General Hospital
- Investigators
- Muhammad Irfan Malik, FCPS, Study director, Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565197
- Sponsor's protocol ID
- LGH008
- Status last verified
- Dec 2020
- First submitted
- 24 Sep 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 7769272Casadevall 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.
PubMed 7985997Garraud 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.
PubMed 28094110Luke 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.
PubMed 20154602Hung 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.
PubMed 21248066Balabolkin MI. [Various problems of thyroidology]. Ter Arkh. 1988;60(9):136-41. No abstract available. Russian.
PubMed 3217871
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convalescent Plasma for Passive Immunization in COVID-19 ICU Patients: An Interventional Study
- ClinicalTrials.gov ID
- NCT04565197
- Acronym / sponsor ID
- LGH008
- Conditions
- SARS-CoV Infection
- Keywords
- COVID-19, Convalescent plasma therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lahore General HospitalOther government
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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. The reason for temporal variation in efficacy is not well understood but could reflect that passive antibody works by neutralizing the initial inoculums, which is likely to be much smaller than that of established disease . As an example, passive antibody therapy for pneumococcal pneumonia was most effective when administered shortly after the onset of symptoms, and there was no benefit if antibody administration was delayed past the third day of disease.
Therapeutic and prophylactic significance was explored in influenza and measles . Transfusion of immune plasma is a standard treatment modality for various viral hemorrhagic fevers . Its efficacy in treating Ebola Virus Disease is also well established . Studies have reported reduction viral load in patients with H1N1 influenza .Efficacy of convalescent plasma has been anecdotally reported in SARS-CoV-2 infections .
The largest study involved the treatment of 80 patients with SARS in Hong Kong. Patients treated before day 14 had improved prognosis defined by discharge from hospital before day 22, consistent with the notion that earlier administration is more likely to be effective .
In the case of SARS-CoV-2, the anticipated mechanism of action by which passive antibody therapy mediated protection is viral neutralization. However, other mechanisms may be possible, such as antibody-dependent cellular cytotoxicity and/or phagocytosis. The only antibody type that is currently available for immediate use SARS-CoV-2 is that found in human convalescent sera.
In China for SARS-CoV-2 disease, it has been found that the convalescent plasma therapy is effective for patients with a disease course exceeding three weeks and whose virus nucleic acid tests continuously to show positive from respiratory tracts specimen. It can speed up virus clearance, increase the numbers of the plasma lymphocytes and NK cells, reduce the level of plasma lactic acid, and improve renal functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Qausi-experimental
| Arm | Type | Receives |
|---|---|---|
| Group intervene with convalescent plasma | Experimental | Biological: convalescent plasmaReview 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 |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| convalescent plasmaAlso: Plasma therapyTransfuse 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 | Group intervene with convalescent plasma |
Primary outcome
clinical outcome after plasma therapy
Time frame: 10 days
Clinical Improvement of COVID-19 patients by giving them passive immunization
1 secondary outcome
Clinical response to treatment
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Background: PubMed 7769272Robbins 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.
- Background: PubMed 7985997Casadevall 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.
- Background: PubMed 28094110Garraud 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.
- Background: PubMed 20154602Luke 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.
- Background: PubMed 21248066Hung 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.
- Background: PubMed 3217871Balabolkin MI. [Various problems of thyroidology]. Ter Arkh. 1988;60(9):136-41. No abstract available. Russian.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Irfan Malik, FCPS study director
Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing convalescent plasma in people with SARS-CoV Infection, run by Lahore General Hospital at 1 site in Pakistan.
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 11 inclusion and 2 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 8 Dec 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 Pakistan. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
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?
clinical outcome after plasma therapy (time frame: 10 days). 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 NCT04565197, which also lists 6 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 8 Dec 2020; AzTrials last refreshed its copy on 4 Nov 2026.