COVID-19Phase 1/2NCT04521309

SARS-CoV-2 Antibodies Based IVIG Therapy for COVID-19 Patients

A Phase 1/2 study testing SARS-CoV-2 antibody based IVIG therapy in people with COVID-19, run by Dow University of Health Sciences at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: SARS-CoV-2 antibody based IVIG therapy
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 sitePakistan
Study dates: 19 Jun 2020to 8 Feb 2021
Phase: Phase 1/2
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Above 18 years of age
Have positive SARS-CoV-2 PCR on nasopharyngeal and/or oropharyngeal swabs
Admitted in isolation ward and ICU of institutes affiliated with DUHS
have severe or critical COVID 19 as judged by the treating physician
Consent given by the patient or first degree relative

Who cannot join

Pregnancy
Previous allergic reaction to immunoglobulin treatment
Ig A deficiency
Patient requiring 2 inotropic agents to maintain blood pressures
Known case of any autoimmune disorder
Acute kidney injury or chronic renal failure
Known case of thromboembolic disorder
Aseptic meningitis

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Dow University of Health Sciences
Karachi, Sindh, 74200

Other trials in Pakistan

About this study

Official title: Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) Antibodies Based Intravenous Immunoglobulin (IVIG) Therapy for Severe and Critically Ill COVID-19 Patients

Severe and critically ill patients will be enrolled in the study (50 patients) after duly filled consent forms. Recipients shall be divided in to 5 groups with 10 patients per group to compare clinical efficacy and safety of patients in clinical phase I/phase II study. Each group shall receive particular single dose of Intravenously administered Immunoglobulins (IVIG) developed from convalescent plasma of recovered COVID-19 individual , an experimental drug along with standard treatment except for control group which will receive standard treatment only.

Read the detailed description

Passive immunization using intravenous immunoglobulins (IVIG) has been tested for treating previous viral outbreaks and holds the potential to save lives in the current crisis. Recently researchers from China reported satisfactory recovery of critically ill Corona Virus Disease 2019 (COVID 19) patients when high dose intravenous immunoglobulin (IVIG) were administered.

Research team at Dow University of Health Sciences has purified immunoglobulin (both SARS-CoV 2 antibodies and existing antibodies) from convalescent plasma of COVID19 individuals and pooled to prepared IVIG formulation to treat severe and critically ill COVID-19 patients. To evaluate safety of the formulation animal (rats) safety trials and survival of all the animals were observed.

It is intended to assess safety and efficacy of experimental the IVIG treatment in severe and critically ill COVID 19 patients through phase I/phase II randomized single blinded clinical trial with fifty study participants. FDA outlined criteria for passive immunization using convalescent plasma, which will be used for recruiting participants in the study.

Conditions: COVID-19
Being tested: SARS-CoV-2 antibody based IVIG therapy
Keywords: COVID19 ( Corona Virus Disease -2019), SARS-CoV-2 (Severe Acute respiratory syndrome Coronavirus 2), Passive Immunization, Intravenous Immunoglobulin (IVIG), Pooled convalescent Plasma, Critically ill COVID-19 patients, Severe COVID-19 patients, Antibody
Medical subject headings: COVID-19

What participants receive

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

SARS-CoV-2 antibody based IVIG therapyBiological
Patient groups will receive IVIG prepared from pooled convalescent plasma from recovered COVID-19 patients. This will be administered sequentially and in varying dosages, infused over a period of 12 hours, intravenously.Additionally, all treatment groups will receive same standard care as control group. Standard Care as per hospital protocol, which may include:
Airway support, Anti-Viral medication, Antibiotics, Fluid Resuscitation, Hemodynamic Support, Steroids, Painkillers, Anti-Pyretics

Study groups in NCT04521309
Study group	Role	What they receive
Control	No intervention	Standard care only n = 10 patients.
IVIG dose: 0.15 g/kg	Experimental	Standard Care + Single dose of 0.20 g/Kg anti-COVID-19 IVIG (experimental drug prepared at DUHS) n= 10 patients Receives: Biological: SARS-CoV-2 antibody based IVIG therapy
IVIG dose: 0.20 g/kg	Experimental	Standard Care + Single dose of 0.25 g/Kg anti-COVID19 IVIG (experimental drug prepared at DUHS) n= 10 patients Receives: Biological: SARS-CoV-2 antibody based IVIG therapy
IVIG dose: 0.25 g/kg	Experimental	Standard Care + Single dose of 0.30 g/Kg anti-COVID19 IVIG (experimental drug prepared at DUHS) n= 10 patients Receives: Biological: SARS-CoV-2 antibody based IVIG therapy
IVIG dose: 0.30 g/kg	Experimental	Standard Care + Single dose of 0.35 g/Kg anti-COVID19 IVIG (experimental drug prepared at DUHS) n= 10 patients Receives: Biological: SARS-CoV-2 antibody based IVIG therapy

What is being measured

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

28 Days mortality
All cause mortality of participants will be monitored for 28 days to assess the safety and efficacy of IVIG treatment.
Measured: 28 days
Requirement of supplemental oxygen support
Number of days required for invasive or non-invasive oxygen supply during hospital stay as per oxygen saturation status of patient
Measured: 28 days
Number of days on assisted ventilation
Number of days a participant will be requiring assisted ventilation both invasive and noninvasive
Measured: 28 days
Days to step down
Shifting from ICU to ward
Measured: 28 days
Days to Hospital Discharge
Duration from day of enrollment in study to Day of hospital discharge
Measured: 28 days
Adverse events during hospital stay
Kidney failure, hypersensitivity with cutaneous or hemodynamic manifestations, aseptic meningitis, hemolytic anemia, leuko-neutropenia, transfusion related acute lung injury (TRALI)
Measured: 28 days
Change in C-Reactive Protein (CRP) levels
Change in C-Reactive Protein (CRP) levels from baseline will be used to monitor inflammation
Measured: 28 days
Change in neutrophil lymphocyte ratio
change in neutrophil lymphocyte ratio from baseline will be used to monitor inflammation
Measured: 28 days

Secondary outcomes (10)

Change in Ferritin levels
change in Ferritin level from baseline will be used to monitor inflammation and immune dysregulation
Measured: 28 days
Change in lactate dehydrogenase (LDH) levels
change in LDH from baseline will be used to monitor infections and tissue health
Measured: 28 days
Change in radiological (X-ray) findings
Any change seen in radiological chest X-ray findings
Measured: 28 days
Days to negative SARS-CoV-2 Polymerase Chain Reaction (PCR) test
Time taken for participant to receive negative COVID-19 PCR test
Measured: 28 days
Anti-SARS-CoV-2 Antibody
Anti-SARS-CoV-2 antibody titre from blood measured by semi-qualitative method
Measured: 28 days
Change in fever
Change in body temperature from baseline will be used to monitor safety and efficacy
Measured: 28 days
Change in Sodium levels
Change in electrolytes (Sodium) seen in participants
Measured: 28 days
Change in Potassium levels
Change in electrolytes (Potassium) seen in participants
Measured: 28 days
Change in Chloride levels
Change in electrolytes (Chloride) seen in participants
Measured: 28 days
Change in Bicarbonate levels
Change in electrolytes (Bicarbonate) seen in participants
Measured: 28 days

Timeline

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

19 Jun 20208 Feb 2021

First posted20 Aug 2020
Study start19 Jun 2020
Primary completion26 Jan 2021
Study completion8 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies 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: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind
Who is masked: Participant
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04521309
Sponsor's protocol ID: biotech001
Status last verified: Mar 2021
First submitted: 7 May 2020
Last updated: 24 Mar 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Cunningham AC, Goh HP, Koh D. Treatment of COVID-19: old tricks for new challenges. Crit Care. 2020 Mar 16;24(1):91. doi: 10.1186/s13054-020-2818-6. No abstract available.
PubMed 32178711
Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Apr;20(4):398-400. doi: 10.1016/S1473-3099(20)30141-9. Epub 2020 Feb 27. No abstract available.
PubMed 32113510
Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.
PubMed 32219428
Buchacher A, Iberer G. Purification of intravenous immunoglobulin G from human plasma--aspects of yield and virus safety. Biotechnol J. 2006 Feb;1(2):148-63. doi: 10.1002/biot.200500037.
PubMed 16892245
Hughes RA, Donofrio P, Bril V, Dalakas MC, Deng C, Hanna K, Hartung HP, Latov N, Merkies IS, van Doorn PA; ICE Study Group. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomised placebo-controlled trial. Lancet Neurol. 2008 Feb;7(2):136-44. doi: 10.1016/S1474-4422(07)70329-0.
PubMed 18178525
Hung IFN, To KKW, Lee CK, Lee KL, Yan WW, Chan K, Chan WM, Ngai CW, Law KI, Chow FL, Liu R, Lai KY, Lau CCY, Liu SH, Chan KH, Lin CK, Yuen KY. Hyperimmune IV immunoglobulin treatment: a multicenter double-blind randomized controlled trial for patients with severe 2009 influenza A(H1N1) infection. Chest. 2013 Aug;144(2):464-473. doi: 10.1378/chest.12-2907.
PubMed 23450336
Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16.
PubMed 25030060
Arabi Y, Balkhy H, Hajeer AH, Bouchama A, Hayden FG, Al-Omari A, Al-Hameed FM, Taha Y, Shindo N, Whitehead J, Merson L, AlJohani S, Al-Khairy K, Carson G, Luke TC, Hensley L, Al-Dawood A, Al-Qahtani S, Modjarrad K, Sadat M, Rohde G, Leport C, Fowler R. Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol. Springerplus. 2015 Nov 19;4:709. doi: 10.1186/s40064-015-1490-9. eCollection 2015.
PubMed 26618098
Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.
PubMed 15616839
Pandey S, Vyas GN. Adverse effects of plasma transfusion. Transfusion. 2012 May;52 Suppl 1(Suppl 1):65S-79S. doi: 10.1111/j.1537-2995.2012.03663.x.
PubMed 22578374
Ali S, Uddin SM, Shalim E, Sayeed MA, Anjum F, Saleem F, Muhaymin SM, Ali A, Ali MR, Ahmed I, Mushtaq T, Khan S, Shahab F, Luxmi S, Kumar S, Arain H, Khan M, Khan AS, Mehmood H, Rasheed A, Jahangeer A, Baig S, Quraishy S. Hyperimmune anti-COVID-19 IVIG (C-IVIG) treatment in severe and critical COVID-19 patients: A phase I/II randomized control trial. EClinicalMedicine. 2021 Jun;36:100926. doi: 10.1016/j.eclinm.2021.100926. Epub 2021 Jun 4.
PubMed 34109306
Ali S, Uddin SM, Ali A, Anjum F, Ali R, Shalim E, Khan M, Ahmed I, M Muhaymin S, Bukhari U, Luxmi S, Khan AS, Quraishy S. Production of hyperimmune anti-SARS-CoV-2 intravenous immunoglobulin from pooled COVID-19 convalescent plasma. Immunotherapy. 2021 Apr;13(5):397-407. doi: 10.2217/imt-2020-0263. Epub 2021 Feb 9.
PubMed 33557591
Ali S, Luxmi S, Anjum F, Muhaymin SM, Uddin SM, Ali A, Ali MR, Tauheed S, Khan M, Bajwa M, Baig SU, Shalim E, Ahmed I, Khan AS, Quraishy S. Hyperimmune anti-COVID-19 IVIG (C-IVIG) Therapy for Passive Immunization of Severe and Critically Ill COVID-19 Patients: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Nov 2;21(1):905. doi: 10.1186/s13063-020-04839-5.
PubMed 33138867

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) Antibodies Based Intravenous Immunoglobulin (IVIG) Therapy for Severe and Critically Ill COVID-19 Patients
ClinicalTrials.gov ID: NCT04521309
Acronym / sponsor ID: biotech001
Conditions: COVID-19
Keywords: COVID19 ( Corona Virus Disease -2019), SARS-CoV-2 (Severe Acute respiratory syndrome Coronavirus 2), Passive Immunization, Intravenous Immunoglobulin (IVIG), Pooled convalescent Plasma, Critically ill COVID-19 patients, Severe COVID-19 patients, Antibody
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Dow University of Health SciencesUniversity, hospital or other
Collaborators: Higher Education Commission (Pakistan)
Study start: 19 Jun 2020 (actual)
Primary completion: 26 Jan 2021 (actual)
Study completion: 8 Feb 2021 (actual)
First posted: 20 Aug 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind (participant)
Number of arms: 5

Arm	Type	Receives
Control	No intervention	–Standard care only n = 10 patients.
IVIG dose: 0.15 g/kg	Experimental	Biological: SARS-CoV-2 antibody based IVIG therapyStandard Care + Single dose of 0.20 g/Kg anti-COVID-19 IVIG (experimental drug prepared at DUHS) n= 10 patients
IVIG dose: 0.20 g/kg	Experimental	Biological: SARS-CoV-2 antibody based IVIG therapyStandard Care + Single dose of 0.25 g/Kg anti-COVID19 IVIG (experimental drug prepared at DUHS) n= 10 patients
IVIG dose: 0.25 g/kg	Experimental	Biological: SARS-CoV-2 antibody based IVIG therapyStandard Care + Single dose of 0.30 g/Kg anti-COVID19 IVIG (experimental drug prepared at DUHS) n= 10 patients
IVIG dose: 0.30 g/kg	Experimental	Biological: SARS-CoV-2 antibody based IVIG therapyStandard Care + Single dose of 0.35 g/Kg anti-COVID19 IVIG (experimental drug prepared at DUHS) n= 10 patients

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Above 18 years of age
Have positive SARS-CoV-2 PCR on nasopharyngeal and/or oropharyngeal swabs
Admitted in isolation ward and ICU of institutes affiliated with DUHS
have severe or critical COVID 19 as judged by the treating physician
Consent given by the patient or first degree relative

Key exclusion criteria (8 listed)

Pregnancy
Previous allergic reaction to immunoglobulin treatment
Ig A deficiency
Patient requiring 2 inotropic agents to maintain blood pressures
Known case of any autoimmune disorder

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
SARS-CoV-2 antibody based IVIG therapyPatient groups will receive IVIG prepared from pooled convalescent plasma from recovered COVID-19 patients. This will be administered sequentially and in varying dosages, infused over a period of 12 hours, intravenously.Additionally, all treatment groups will receive same standard care as control group. Standard Care as per hospital protocol, which may include: Airway support, Anti-Viral medication, Antibiotics, Fluid Resuscitation, Hemodynamic Support, Steroids, Painkillers, Anti-Pyretics	Biological	IVIG dose: 0.15 g/kg, IVIG dose: 0.20 g/kg, IVIG dose: 0.25 g/kg, IVIG dose: 0.30 g/kg

Primary outcome

28 Days mortality
Time frame: 28 days
All cause mortality of participants will be monitored for 28 days to assess the safety and efficacy of IVIG treatment.
Requirement of supplemental oxygen support
Time frame: 28 days
Number of days required for invasive or non-invasive oxygen supply during hospital stay as per oxygen saturation status of patient
Number of days on assisted ventilation
Time frame: 28 days
Number of days a participant will be requiring assisted ventilation both invasive and noninvasive
Days to step down
Time frame: 28 days
Shifting from ICU to ward
Days to Hospital Discharge
Time frame: 28 days
Duration from day of enrollment in study to Day of hospital discharge
Adverse events during hospital stay
Time frame: 28 days
Kidney failure, hypersensitivity with cutaneous or hemodynamic manifestations, aseptic meningitis, hemolytic anemia, leuko-neutropenia, transfusion related acute lung injury (TRALI)
Change in C-Reactive Protein (CRP) levels
Time frame: 28 days
Change in C-Reactive Protein (CRP) levels from baseline will be used to monitor inflammation
Change in neutrophil lymphocyte ratio
Time frame: 28 days
change in neutrophil lymphocyte ratio from baseline will be used to monitor inflammation

10 secondary outcomes

Change in Ferritin levels
Time frame: 28 days
Change in lactate dehydrogenase (LDH) levels
Time frame: 28 days
Change in radiological (X-ray) findings
Time frame: 28 days
Days to negative SARS-CoV-2 Polymerase Chain Reaction (PCR) test
Time frame: 28 days
Anti-SARS-CoV-2 Antibody
Time frame: 28 days
Change in fever
Time frame: 28 days
Change in Sodium levels
Time frame: 28 days
Change in Potassium levels
Time frame: 28 days
Change in Chloride levels
Time frame: 28 days
Change in Bicarbonate levels
Time frame: 28 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
Background: PubMed 32178711Cunningham AC, Goh HP, Koh D. Treatment of COVID-19: old tricks for new challenges. Crit Care. 2020 Mar 16;24(1):91. doi: 10.1186/s13054-020-2818-6. No abstract available.
Background: PubMed 32113510Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Apr;20(4):398-400. doi: 10.1016/S1473-3099(20)30141-9. Epub 2020 Feb 27. No abstract available.
Background: PubMed 32219428Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.
Background: PubMed 16892245Buchacher A, Iberer G. Purification of intravenous immunoglobulin G from human plasma--aspects of yield and virus safety. Biotechnol J. 2006 Feb;1(2):148-63. doi: 10.1002/biot.200500037.
Background: PubMed 18178525Hughes RA, Donofrio P, Bril V, Dalakas MC, Deng C, Hanna K, Hartung HP, Latov N, Merkies IS, van Doorn PA; ICE Study Group. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomised placebo-controlled trial. Lancet Neurol. 2008 Feb;7(2):136-44. doi: 10.1016/S1474-4422(07)70329-0.
Background: PubMed 23450336Hung IFN, To KKW, Lee CK, Lee KL, Yan WW, Chan K, Chan WM, Ngai CW, Law KI, Chow FL, Liu R, Lai KY, Lau CCY, Liu SH, Chan KH, Lin CK, Yuen KY. Hyperimmune IV immunoglobulin treatment: a multicenter double-blind randomized controlled trial for patients with severe 2009 influenza A(H1N1) infection. Chest. 2013 Aug;144(2):464-473. doi: 10.1378/chest.12-2907.
Background: PubMed 25030060Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16.
Background: PubMed 26618098Arabi Y, Balkhy H, Hajeer AH, Bouchama A, Hayden FG, Al-Omari A, Al-Hameed FM, Taha Y, Shindo N, Whitehead J, Merson L, AlJohani S, Al-Khairy K, Carson G, Luke TC, Hensley L, Al-Dawood A, Al-Qahtani S, Modjarrad K, Sadat M, Rohde G, Leport C, Fowler R. Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol. Springerplus. 2015 Nov 19;4:709. doi: 10.1186/s40064-015-1490-9. eCollection 2015.
Background: PubMed 15616839Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.
Background: PubMed 22578374Pandey S, Vyas GN. Adverse effects of plasma transfusion. Transfusion. 2012 May;52 Suppl 1(Suppl 1):65S-79S. doi: 10.1111/j.1537-2995.2012.03663.x.
Derived from this study: PubMed 34109306Ali S, Uddin SM, Shalim E, Sayeed MA, Anjum F, Saleem F, Muhaymin SM, Ali A, Ali MR, Ahmed I, Mushtaq T, Khan S, Shahab F, Luxmi S, Kumar S, Arain H, Khan M, Khan AS, Mehmood H, Rasheed A, Jahangeer A, Baig S, Quraishy S. Hyperimmune anti-COVID-19 IVIG (C-IVIG) treatment in severe and critical COVID-19 patients: A phase I/II randomized control trial. EClinicalMedicine. 2021 Jun;36:100926. doi: 10.1016/j.eclinm.2021.100926. Epub 2021 Jun 4.
Derived from this study: PubMed 33557591Ali S, Uddin SM, Ali A, Anjum F, Ali R, Shalim E, Khan M, Ahmed I, M Muhaymin S, Bukhari U, Luxmi S, Khan AS, Quraishy S. Production of hyperimmune anti-SARS-CoV-2 intravenous immunoglobulin from pooled COVID-19 convalescent plasma. Immunotherapy. 2021 Apr;13(5):397-407. doi: 10.2217/imt-2020-0263. Epub 2021 Feb 9.
World Health Organization (WHO) technical guidance on COVID-19Link provided by the sponsor.
WHO guidelines for Use of Convalescent Whole Blood or Plasma Collected from Patients Recovered from Ebola Virus Disease for Transfusion, as an Empirical Treatment during OutbreaksLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Dr.Shaukat Ali, PhD principal investigator

Dow University of Health Sciences, Principal Dow College of Biotechnology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SARS-CoV-2 antibody based IVIG therapy in people with COVID-19, run by Dow University of Health Sciences 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 24 Mar 2021. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

28 Days mortality (time frame: 28 days). The study lists 8 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 NCT04521309, which also lists 13 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 24 Mar 2021.