Intravenous Immunoglobulins for the Treatment of Covid-19 Patients: a Clinical Trial

NCT04548557 | Unknown Phase 3

• 1 other identifier: UniversityHSL-IVIG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The current project is based on the immunological studies covering the potential of disease induced immunoglobulins as treatment regime. We would be able to generate the concentrated antibodies specific against coronavirus (Covid-19). These antibodies can be used as serum therapy. Aside from a Covid-19 vaccine, antibodies from recovered patients could provide a short-term "passive immunization" to the disease. Those antibodies can be extracted from the blood serum of surviving patients and then injected into infected people. Passive immunization usually lasts for a few weeks or months, after which those borrowed or donated antibodies, get broken down by the host body within about 30 days. While drugs to treat patients with covid-19, and vaccines to prevent infection are being developed, a fast acting, stopgap serum therapy could be useful as a first aid for high-risk patients.

Conditions

Covid19

Keywords

Covid 19; intravenous immunogloulin therapy; passive immunization

Outcome Measures

Primary Outcomes (2)

• In hospital days

  total number of days the patient remain in hospital

  14 days or discharge

• 14 day mortality

  mortality if any in the study duration of 14 days

  14 days

Secondary Outcomes (7)

• D-dimers

  7 days

• C-reactive protein

  7 days

• Oxygen saturation

  7 days

• TNF alpha

  7 days

• IL-6

  7 days

Study Arms (2)

Control

NO INTERVENTION

They will not receive any intervention

IVIG group

EXPERIMENTAL

They will reveive intravenous immunoglobulin therapy

Biological: intravenous immunoglobulin therapy

Interventions

intravenous immunoglobulin therapy BIOLOGICAL

It is passive immunization therapy. Plasma therapy is subjected to moderate to severe patients specially, while all effected individuals can take benefit of immunoglobulin therapy because dose of immunoglobulins can be controlled

IVIG group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 yrs
• Both genders
• Lab Confirmed COVID-19 infection by PCR or plasma positive of specific antibody against COVID-19
• In hospital treatment ≥ 72 hours
• Admitted patients
• Mild to moderately severe patients

You may not qualify if:

• Exist of other evidences that can explain pneumonia including but not limited to influenza A virus, influenza B virus, bacterial pneumonia, fungal pneumonia, noninfectious causes, etc.
• Patients with respiratory diseases other than Covid-19 infection
• Pregnant and breastfeeding women

Sponsors & Collaborators

• University of Health Sciences Lahore: lead
• University of Lahore: collaborator
• Amson Vaccine and Pharma (Pvt) Limited: collaborator

Study Sites (1)

University of Health Sciences

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (11)

• Gao GF. From "A"IV to "Z"IKV: Attacks from Emerging and Re-emerging Pathogens. Cell. 2018 Mar 8;172(6):1157-1159. doi: 10.1016/j.cell.2018.02.025.

  PMID: 29522735 BACKGROUND

• Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24. No abstract available.

  PMID: 31986257 BACKGROUND

• Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.

  PMID: 31978945 BACKGROUND

• Wu F, Zhao S, Yu B, Chen YM, Wang W, Song ZG, Hu Y, Tao ZW, Tian JH, Pei YY, Yuan ML, Zhang YL, Dai FH, Liu Y, Wang QM, Zheng JJ, Xu L, Holmes EC, Zhang YZ. A new coronavirus associated with human respiratory disease in China. Nature. 2020 Mar;579(7798):265-269. doi: 10.1038/s41586-020-2008-3. Epub 2020 Feb 3.

  PMID: 32015508 BACKGROUND

• Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.

  PMID: 32015507 BACKGROUND

• Jiang S, Shi Z, Shu Y, Song J, Gao GF, Tan W, Guo D. A distinct name is needed for the new coronavirus. Lancet. 2020 Mar 21;395(10228):949. doi: 10.1016/S0140-6736(20)30419-0. Epub 2020 Feb 19. No abstract available.

  PMID: 32087125 BACKGROUND

• Lu G, Hu Y, Wang Q, Qi J, Gao F, Li Y, Zhang Y, Zhang W, Yuan Y, Bao J, Zhang B, Shi Y, Yan J, Gao GF. Molecular basis of binding between novel human coronavirus MERS-CoV and its receptor CD26. Nature. 2013 Aug 8;500(7461):227-31. doi: 10.1038/nature12328. Epub 2013 Jul 7.

  PMID: 23831647 BACKGROUND

• Wevers BA, van der Hoek L. Recently discovered human coronaviruses. Clin Lab Med. 2009 Dec;29(4):715-24. doi: 10.1016/j.cll.2009.07.007.

  PMID: 19892230 BACKGROUND

• Ksiazek TG, Erdman D, Goldsmith CS, Zaki SR, Peret T, Emery S, Tong S, Urbani C, Comer JA, Lim W, Rollin PE, Dowell SF, Ling AE, Humphrey CD, Shieh WJ, Guarner J, Paddock CD, Rota P, Fields B, DeRisi J, Yang JY, Cox N, Hughes JM, LeDuc JW, Bellini WJ, Anderson LJ; SARS Working Group. A novel coronavirus associated with severe acute respiratory syndrome. N Engl J Med. 2003 May 15;348(20):1953-66. doi: 10.1056/NEJMoa030781. Epub 2003 Apr 10.

  PMID: 12690092 BACKGROUND

• Zaki AM, van Boheemen S, Bestebroer TM, Osterhaus AD, Fouchier RA. Isolation of a novel coronavirus from a man with pneumonia in Saudi Arabia. N Engl J Med. 2012 Nov 8;367(19):1814-20. doi: 10.1056/NEJMoa1211721. Epub 2012 Oct 17.

  PMID: 23075143 BACKGROUND

• Azhar EI, El-Kafrawy SA, Farraj SA, Hassan AM, Al-Saeed MS, Hashem AM, Madani TA. Evidence for camel-to-human transmission of MERS coronavirus. N Engl J Med. 2014 Jun 26;370(26):2499-505. doi: 10.1056/NEJMoa1401505. Epub 2014 Jun 4.

  PMID: 24896817 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

gamma-Globulins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Javed Akram, MBBS,FRCP,MRCP

  Saglik Bilimleri Universitesi

  STUDY CHAIR

• Fridoon J Ahmad, Ph.D

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

riffat mehboob, Ph.D

CONTACT

+923313380909; mehboob.riffat@gmail.com

Fridoon J Ahmad, Ph.D

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor,

Model Details: one group in conventional with routine therapy and interventional group will receive intravenous immunoglobulin therapy

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 14, 2020
• Study Start: September 15, 2020
• Primary Completion: October 15, 2020
• Study Completion: November 15, 2020
• Last Updated: September 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)