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NCT04474340
COVID-19 Convalescent Plasma Treatment in SARS-CoV-2 Infected Patients
Phase 1 trial testing COVID-19 Convalscent Plasma in Moderate COVID-19 Pneumonia, Severe COVID-19 Pneumonia in 300 participants. Status unknown.
30 September 2020
Quick facts
| Lead sponsor | Ministry of Health, Kuwait |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 21 May 2020 |
| Primary completion | 30 September 2020 |
| Estimated completion | 30 December 2020 |
| Sites | 1 location across Kuwait |
Drugs / interventions tested
- COVID-19 Convalscent Plasma — full drug profile →
Conditions studied
- Moderate COVID-19 Pneumonia, Severe COVID-19 Pneumonia — all drugs for Moderate COVID-19 Pneumonia, Severe COVID-19 Pneumonia →
- Pneumonia, Viral — all drugs for Pneumonia, Viral →
Sponsor
Ministry of Health, Kuwait
Who can join
Adults 15 to 85, any sex, with Moderate COVID-19 Pneumonia, Severe COVID-19 Pneumonia or Pneumonia, Viral. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Due to the limitations of COVID-19 treatment and in the absence of licensed antiviral for COVID-19, the historical choice of therapeutic convalescent plasma (CP) is considered especially against RNA viruses .It was known that convalescent plasma does not only neutralize the pathogens but provide passive immunomodulatory properties that allows the recipient to control the exaggerated inflammatory cascade. However, still there is a lack of understanding of the mechanism of action of CCP therapeutic components. Reports from open label trials and case series show that CCP is safe and might be effective in severe cases with COVID-19 . Therefore, the World health organisation (WHO) and Food and Drug Administration (FDA) issued guidelines for the CCP usage and standardised the donor selection , which was further supported by Emergency use Authorisation (EUA) . Therefore, the aim in the current study is to assess the effect of CCP on time to clinical improvement, hospital mortality and to evaluate the changes on oxygen saturation and laboratory markers (lymphocyte counts and C-reactive protein) compared with standard treatment alone in patients with moderate or severe COVID-19 disease.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04474340
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04474340 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ministry of Health, Kuwait
- Last refreshed: 21 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04474340.
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