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High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent PlasmaWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug2956 plasma therapy using convalescent plasma with antibody against SARS-CoV-2 Wiki 1.00
drug2114 Routine care for COVID-19 patients Wiki 0.71

Correlated MeSH Terms (4)

Name (Synonyms) Correlation
D011014 Pneumonia NIH 0.06
D007239 Infection NIH 0.06
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.06

There is one clinical trial.

Clinical Trials

1 Efficacy and Safety of High-Titer Anti-SARS-CoV-2 (COVID19) Convalescent Plasma for Hospitalized Patients With Infection Due to COVID-19 to Decrease Complications: A Phase II Trial

This is a single arm phase II trial to assess efficacy and confirm safety of infusions of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms,with or without confirmed interstitial COVID-19 pneumonia by chest Xray or CT. A total of 29 eligible subjects will be enrolled to receive anti-SARS-CoV-2 plasma.Outcomes will be compared to hospitalized controls with confirmed COVID-19 disease through retrospective chart review.

NCT04374565 Corona Virus Infection SARS-CoV 2 SARS Pneumonia Pneumonia Drug: High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Will be done by comparing the admission rate to the ICU between patients who received convalescent plasma and a control group who did not enroll in the study, or receive another experimental therapy.

Measure: Transfer to ICU

Time: Days 0 - 60

Description: Will be done by comparing the 28 day mortality rate between enrolled subjects and the control group.

Measure: 28 day mortality

Time: Days 0 - 60

Secondary Outcomes

Description: Will be collected from time of enrollment until completion of the study. The adverse events will be evaluated by CTCAE V5.0 and MedDRA.

Measure: Cumulative incidence of serious adverse events

Time: Days 0 - 60

Description: Will be done by collecting respiratory tract swabs and testing for SARS-CoV-2 positivity.

Measure: Rates and duration of SARS-CoV-2

Time: Days 0, 7, 14, and 21

Description: Serum or plasma will be collected and analyzed for SARS-CoV-2 antibody.

Measure: Serum of plasma antibody titer to SARS-CoV-2

Time: Days 0, 7, 14, and 28

Description: Blood will be collected and analyzed for cellular and humoral response.

Measure: Cellular and humoral immune response

Time: Days 0, 7, 14, 28

Description: All days where a supplemental oxygen is needed will be recorded as a concomitant medication and will be subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the supplemental oxygen free days.

Measure: Supplemental oxygen free days

Time: Days 0-28

Description: All days where a ventilator is needed will be recorded as a concomitant procedure and will be subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the ventilator free days.

Measure: Ventilator free days

Time: Days 0 - 28

Description: All days where the participant is admitted to the ICU will be recorded and subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the ICU free days.

Measure: ICU free days

Time: Days 0 - 28

Description: The patient will be evaluated throughout their enrollment in the study. The score will be evaluated to see if the score improved or worsened throughout their admission.

Measure: Sequential organ failure assessment score

Time: days 0, 1, 4, 7, 14, 21, 28

Description: Concomitant medications will be recorded throughout the patients participation in the study and vasopressors will be recorded, if they are needed.

Measure: Need for vasopressors

Time: Days 0 - 60

Description: Renal function will be assessed throughout the patients participation in the study. If renal replacement therapy is needed, it will be captured as a concomitant procedure.

Measure: Need for renal replacement therapy

Time: Days 0 - 60

Description: Respiratory function will be assessed throughout the patients participation in the study. If ECMO is needed, it will be captured as a concomitant procedure.

Measure: Need for extracorporeal membrane oxygenation (ECMO)

Time: Days 0 - 60

Description: Will be calculated from the date the patient entered the hospital until they were discharged.

Measure: Hospital length of stay (LOS)

Time: Days 0-60

Description: Will be calculated from the date the patient entered the ICU until they were discharged from the ICU.

Measure: ICU LOS

Time: days 0 - 60

Description: All adverse events will be recorded and evaluated by CTCAE v.5.0. All grade 3 and 4 AEs will be calculated to determine safety of convalescent plasma.

Measure: Grade 3 or 4 Adverse Events (AEs)

Time: days 0 - 60

Related HPO nodes (Using clinical trials)

HP:0002090: Pneumonia
Genes 220
KMT2D OSTM1 GBA RSPH1 DOCK8 NKX2-1 RNU4ATAC SPAG1 RAG1 MCIDAS AFF4 TNFRSF13C DNAH1 NOTCH3 CD19 ALMS1 NADK2 UNC119 SFTPC FOXN1 CD79B CFAP221 CD81 SAMD9 MED25 ZAP70 RAG2 IGLL1 DNAAF1 RPGR STK36 LTBP3 PLOD1 DNAH9 BTK TERT COL11A2 OFD1 TNFRSF11A LRBA RSPH4A CD19 NME8 SMARCD2 GAS8 CFTR TNFRSF13B CCDC65 CFAP298 COL11A2 RAG1 ORC6 P4HTM MAN2B1 CFAP300 JAK3 CACNA1C ICOS SETBP1 TNFRSF13C SPEF2 LIG4 NIPBL STAT3 ZMYND10 IL7R MAN2B1 HLA-DQA1 IL21R SELENON SP110 ACADVL CCDC39 ARMC4 NSMCE3 NFIX DNAI2 ACP5 PTPRC ZAP70 KIAA0586 FCGR2A NFKB2 NEK10 MTHFD1 EGFR RYR1 ADA DNAI1 TGFB1 DNAAF6 IL2RG KCNJ6 DCLRE1C CCDC103 IGHM GNPTAB DNAAF4 PNP CFB DCLRE1C TAF1 CARD11 USB1 ADA ICOS FMO3 IL2RG HLA-DQB1 GFI1 SFTPA2 ICOS CD3D FOXJ1 CRLF1 ELANE IL2RG SRP54 NFKB1 PANK2 GAS2L2 CD247 IRF8 GAS8 RAG2 CCDC151 WAS ZBTB24 CD3E DNAL1 EXTL3 SLC35A1 NCF1 TK2 MS4A1 IFNGR1 RNF168 RMRP RSPH9 NHLRC1 MUC5B TNFRSF13C DNAH5 DNMT3B RNF125 EPM2A TTC12 JAK3 LEP RAC1 CYBA PGM3 NOS1 DDR2 AFF4 TBC1D24 CHD7 TNFRSF13B OFD1 DNAI1 RANBP2 TCIRG1 DNAJB13 CR2 CCDC40 IL2RG NCF2 RAG2 SLC25A24 SGCG WDR19 FOXP3 RNU4ATAC ACTA1 UBB CFAP410 BTK TTC25 CARD11 DNAAF2 CXCR4 MASP2 DRC1 TBCD DCLRE1C CYBB RSPH3 LRRC6 PIGN TNFSF12 DNAAF5 CCNO CSPP1 CR2 SLC35C1 HYDIN TIMM8A NBN NFKB2 CCDC114 CASP8 ADA IL7R CCDC114 TNFSF12 BTK LRRC56 PEPD BLNK CD55 GRHL3 NBN PRKCD KPTN PMM2 DNAAF3 KDM6A POLA1 RAG1 DNAH11
Protein Mutations 6
A2063G G551D K55R L460D R287Q S1009A
SNP 0