Covid 19 Research using Clinical Trials (Home Page)
Report for D003289: Convalescence NIH
(Synonyms: Convalescence)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (15)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2265 | Single Dose of Hydroxychloroquine Wiki | 0.63 |
| drug1226 | Interferon-β 1a Wiki | 0.45 |
| drug2735 | allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC) Wiki | 0.45 |
| drug1240 | Intervention group_rehabilitation program Wiki | 0.45 |
| drug1355 | Lopinavir / Ritonavir Wiki | 0.45 |
| drug1521 | Moxibustion plus Cupping Wiki | 0.45 |
| drug2355 | Standards of Care Wiki | 0.45 |
| drug1236 | Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic Wiki | 0.45 |
| drug2592 | Umifenovir Wiki | 0.45 |
| drug181 | Anti- SARS-CoV-2 Plasma Wiki | 0.45 |
| drug1253 | Intravenous saline injection (Placebo) Wiki | 0.45 |
| drug2137 | SARS-CoV-2 non-immune Plasma Wiki | 0.45 |
| drug1219 | Interferon Beta-1A Wiki | 0.22 |
| drug658 | Convalescent plasma Wiki | 0.22 |
| drug2787 | convalescent plasma Wiki | 0.22 |
Correlated MeSH Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D018352 | Coronavirus Infections NIH | 0.04 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.02 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 5 clinical trials
Clinical Trials
1 Convalescent Plasma to Stem Coronavirus: A Randomized, Blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19
Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28.
NCT04323800 Coronavirus Convalescence Biological: Anti- SARS-CoV-2 Plasma Biological: SARS-CoV-2 non-immune Plasma MeSH:Coronavirus Infections Convalescence
Primary Outcomes
Description: Comparison of proportions of cumulative incidence of development of SARS-Cov-2 infection (symptoms compatible with infection and/or + molecular testing) regardless of disease severity, following high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to COVID-19.
Measure: Efficacy of treatment at Day 28 Time: Day 28Description: Cumulative incidence of serious adverse events categorized separately as either severe infusion reactions and Acute Respiratory Distress Syndrome during the study period.
Measure: Safety of treatment with high-titer Anti- SARS-CoV-2 plasma versus control - 1 Time: Up to Day 28Description: Cumulative incidence of grade 3 and 4 adverse events during the study period
Measure: Safety of treatment with high-titer Anti- SARS-CoV-2 plasma versus control - 2 Time: Up to Day 28Secondary Outcomes
Description: Cumulative incidence of disease severity between the anti-SARS-CoV-2 convalescent plasma and control groups after individuals develop SARS-CoV-2 infection. Severity of disease will be measured using a clinical event scale of disease severity (evaluated up to Day 28): Death Requiring mechanical ventilation and/or in ICU non-ICU hospitalization, requiring supplemental oxygen; non-ICU hospitalization, not requiring supplemental oxygen; Not hospitalized, but with clinical and laboratory evidence of COVID-19 infection
Measure: Cumulative incidence of disease severity Time: up to Day 28Other Outcomes
Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day -1 or day 0 (baseline).
Measure: Anti-SARS-CoV-2 titers Day 0 Time: Day 0Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 1.
Measure: Anti-SARS-CoV-2 titers Day 1 Time: Day 1Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 7.
Measure: Anti-SARS-CoV-2 titers Day 7 Time: Day 7Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 14.
Measure: Anti-SARS-CoV-2 titers Day 14 Time: Day 14Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 90.
Measure: Anti-SARS-CoV-2 titers Day 90 Time: Day 90Description: Compare the rates of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.
Measure: Rates of SARS-CoV-2 PCR positivity Time: Up to day 28Description: Compare the duration (days) of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.
Measure: Duration of SARS-CoV-2 PCR positivity Time: Up to day 28Description: Compare the peak quantity levels of SARS-CoV-2 RNA amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 1, 7, 14 and 28 days.
Measure: Peak quantity levels of SARS-CoV-2 RNA Time: Up to day 282 DETERMINATION OF THE DOSE AND EFFECTIVENESS OF CONVALESCENT PLASMA IN SEVERELY AND VERY SEVERELY ILL PATIENTS BY COVID-19
The present study will try to respond first in an initial phase, what is the minimum effective dose necessary of convalescent plasma for getting better in severly ill (not intubated) or very severely ill (intubated) patients. Once the dose will be determined by each type of patient group (severely ill vs. very severely ill) has been determined, phase 2 of the study will begin, where the safety and efficacy of the use of plasma will be evaluated based on clinical, imaging and laboratory criteria. So, our hypotheses are: 1. Is there a minimum effective dose to treat seriously ill patients with convalescent plasma with COVID-19? 2. the plasma dose with the minimum effective effect will improve the clinical, laboratory and clearance conditions of the presence of the virus in the severely ill patient?
NCT04356482 COVID-19 SARS SARS-CoV 2 Convalescence Plasma Doses Biological: convalescent plasma MeSH:Convalescence
Primary Outcomes
Description: no fever, respiratory improvement and blood oxygenation (Sat02, Sat02 / Fi02), general laboratory improvement.
Measure: Clinical improvement Time: day -1 to day +22Description: before convalescent plasma infusion, the CT image will be compared and subsequently the evolution of images in the CT will be evaluated every 72 hours on 3 times .
Measure: improvement in tomographic image Time: day -1 to day +12Description: the patients will be evaluated on three occasions the positivity of the test (PCR-RT). If two of them are negative, it will be defined as a virus-free patient.
Measure: test positivity for COVID-19 Time: day +6 to day +12Description: Patients will be evaluated for adverse events during the plasma infusion up to 30 days after that. Especially mild and severe allergic reactions (anaphylaxis), other issues like TRALI.
Measure: early and late complications associated to convalescent plasma Time: day 0 to day +30Secondary Outcomes
Description: days of stay at ICU will be evaluated
Measure: days at ICU Time: day 0 to day +303 Moxibustion Plus Cupping in Convalescent Patients With COVID-19: A Randomized Clinical Trial
This trial is designed to evaluate the efficacy and safety of moxibustion plus cupping in the convalescence of COVID-19.
NCT04374084 COVID-19 Convalescence Other: Moxibustion plus Cupping MeSH:Convalescence
Primary Outcomes
Description: At the end of week 4, the average visual analogue scale (VAS) score of main clinical symptoms in the past 1 week changed from baseline. The VAS score ranges from 0 to 100 point and the higher scores mean worse symptoms (The main clinical symptoms including: Cough /chest tightness/shortness of breath after exercise/asthenia).
Measure: The change of the average VAS score from baseline to week 4 Time: week 4Secondary Outcomes
Description: At the end of week 2, week 4 and week 8, the average VAS score of main clinical symptoms in the past 1 week changed from baseline. VAS score measure is as same as the primary outcome.
Measure: The change of the average VAS score from baseline to week 2, and week 8 Time: week 2 and week 8Description: At the end of week 2, week 4 and week 8, the severity VAS score of main clinical symptoms in the past 1 week changed from baseline. VAS score measure is as same as the primary outcome.
Measure: The change of the severity VAS score from baseline to week 2, week 4 and week 8 Time: week 2, week 4 and week 8Description: At the end of week 2, week 4 and week 8, the average insomnia VAS score in the past 1 week changed from baseline. VAS score measure is as same as the primary outcome.
Measure: The change of the average insomnia VAS score from baseline to week 2, week 4 and week 8 Time: week 2, week 4 and week 8Description: At the end of week 2, week 4 and week 8, the average VAS score of sweating, mental fatigue, anorexia and nervousness in the past 1 week changed from baseline. VAS score measure is as same as the primary outcome.
Measure: The change of the average VAS score of sweating, mental fatigue, anorexia and nervousness from baseline to week 2, week 4 and week 8 Time: week 2, week 4 and week 8Description: At the end of week 2, week 4 and week 8, the average times of diarrhea and complete spontaneous bowel movement in the past 1 week changed from baseline.
Measure: The change of the average times of diarrhea and complete spontaneous bowel movement to week 2, week 4 and week 8 Time: week 2, week 4 and week 8Description: At the end of week 2, week 4 and week 8, the proportion of patients whose average and severity VAS scores of main clinical symptoms (except diarrhea and constipation) in the past 1 week changed from baseline decreased 50% and 75%. VAS score measure is as same as the primary outcome.
Measure: The proportion of patients with 50%/75% improvement of clinical symptoms to week 2, week 4 and week 8 Time: week 2, week 4 and week 8Description: At the end of week 2, week 4 and week 8, the walking distance of six-minute-walking test changed from baseline.
Measure: The change of the walking distance of six-minute-walking test from baseline to week 2, week 4 and week 8 Time: week 2, week 4 and week 8Description: At the end of week 2, week 4 and week 8, the lowest oxygen saturation of six-minute-walking test changed from baseline.
Measure: The change of the lowest oxygen saturation of six-minute-walking test from baseline to week 2, week 4 and week 8 Time: week 2, week 4 and week 8Description: At the end of week 2 and week 4, the proportion of patients in recovery of pulmonary function in all participants.
Measure: The proportion of patients in recovery of pulmonary function on week 2 and week 4 Time: week 2 and week 4Description: Lung CT shows complete absorption of inflammation.
Measure: The proportion of patients whose lung CT return to normal on week 4 Time: week 4Description: At the end of week 4 and week 8, the WHO Quality of Life-BREF (WHO QOL-BREF) score changed from baseline. The higher scores mean better outcome.
Measure: The change of the WHO QOL-BREF score from baseline to week 4 and week 8 Time: week 4 and week 8Description: At the end of week 4 and week 8, the Self-Rating Anxiety Scale (SAS) score changed from baseline. The higher scores mean worse outcome.
Measure: The change of the SAS score from baseline to week 4 and week 8 Time: week 4 and week 8Description: At the end of week 4 and week 8, the Self-Rating Depression Scale (SDS) score changed from baseline.The higher scores mean worse outcome.
Measure: The change of the SDS score from baseline to week 4 and week 8 Time: week 4 and week 8Description: At the end of week 4, the blood C-reactive protein (CRP) value changed from baseline.
Measure: The change of the blood CRP value from baseline to week 4 Time: week 4Description: At the end of week 4, the blood lymphocyte count (LYMPH#) changed from baseline.
Measure: The change of the blood LYMPH# value from baseline to week 4 Time: week 4Description: At the end of week 4, the percentage of blood neutrophils (NEUT%) value changed from baseline.
Measure: The change of the blood NEUT% value from baseline to week 4 Time: week 4Description: Divide the patients into two subgroups (the non-elderly ≤ 40 years old; the elderly > 40 years old ) according to the baseline data. At the end of week 4, analyze the average VAS score of main clinical symptoms in the past 1 week changed from baseline in the two age groups. VAS score measure is as same as the primary outcome.
Measure: The change of the average VAS score from baseline to week 4 in different age groups. Time: week 4Description: Divide the patients into two subgroups (man; woman) according to the baseline data. At the end of week 4, analyze the average VAS score of main clinical symptoms in the past 1 week changed from baseline in the two gender groups. VAS score measure is as same as the primary outcome.
Measure: The change of the average VAS score from baseline to week 4 in different gender groups. Time: week 4Description: Divide the patients into four subgroups ( mild type；common type；severe type；critical type) according to the baseline data. At the end of week 4, analyze the average VAS score of main clinical symptoms in the past 1 week changed from baseline in the four clinical classification groups. VAS score measure is as same as the primary outcome.
Measure: The change of the average VAS score from baseline to week 4 in different clinical classification of COVID-19. Time: week 44 Convalescent Plasma Transfusion Therapy in Severe COVID-19 Patients- a Tolerability, Efficacy and Dose-response Phase II RCT
As of March 18, 2020, COVID-19 cases were reported in approximately 195 countries. No specific therapeutic agents or vaccines for COVID-19 are available. Several therapies, such as remdesivir and favipiravir, are under investigation, but the antiviral efficacy of these drugs is not yet known. The use of convalescent plasma (CP) was recommended as an empirical treatment during outbreaks of Ebola virus in 2014. A protocol for treatment of Middle East respiratory syndrome coronavirus (MERS-CoV) with CP was established in 2015. This approach with other viral infections such as SARS-CoV, H5N1 avian influenza, and H1N1 influenza also suggested that transfusion of CP was effective. In previous reports, most of the patients received the CP by single transfusion. In a study involving patients with pandemic influenza A(H1N1) 2009 virus infection, treatment of severe infection with CP (n = 20 patients) was associated with reduced respiratory tract viral load, serum cytokine response, and mortality. In another study involving 80 patients with SARS, the administration of CP was associated with a higher rate of hospital discharge at day 22 from symptom onset compared with patients who did not receive CP. Accordingly, these findings raise the hypothesis that use of CP transfusion could be beneficial in patients infected with SARS-CoV-2. The objective of this study is to describe the initial clinical experience with CP transfusion administered to severe COVID-19 patients. The primary endpoint of this trial would be to assess the tolerability, efficacy, and dose-response of CP in severe COVID-19 patients. The secondary endpoint would be to assess the clinical and laboratory parameters after therapy, in-hospital mortality, length of hospital stay, reduction in the proportion of deaths, length of ICU stay, requirement of ventilator and duration of ventilator support. All RT-PCR positive cases with features of severe infection will be enrolled in this study. Apheretic CP will be collected from a recovered patient (consecutive two RT-PCR samples negative) between day 22 to 35 days of recovery and those with the antibody titre above 1:320. This RCT will consist of three arms, a. standard care, b. standard care and 200 ml CP and c. standard care and 400 ml CP as a single transfusion. Twenty (20) patients will be enrolled for each arm. Randomization will be done by someone not associated with the care or assessment of the patients by means of a random number table. Allocations will be concealed in sequentially numbered, opaque, sealed envelopes. Clinical parameters [fever, cough, dyspnea, respiratory rate, PaO2/ FiO2 level, pulse, BP, the requirement of O2, and others] will be recorded before and after CP. Laboratory parameters such as complete blood count, CRP, chest X-ray, SGPT, SGOT, S. Ferritin, and serum antibody titre will be measured before and after transfusion. Allergic or serum sickness-like reactions will be noted and adjusted with outcome. Laboratory tests including RT-PCR will be done at BSMMU virology and laboratory medicine department. Apheretic plasma will be collected at the transfusion medicine department of SHNIBPS hospital, ELISA, antibody titre will be done at CMBT, and patients will be enrolled at DMC and MuMCH. All necessary screening tests will be done before transfusion. Graphpad Prism v 7.0 will be used for analysis. One way ANOVA test, a non-parametric Mann-Whitney test, and a Kruskal-Wallis test will be performed to compare the arms. For parametric outcomes, the investigators will compare the odds ratios across the pairs.
NCT04403477 Covid19 Convalescence Biological: Convalescent plasma MeSH:Convalescence
Primary Outcomes
Description: % of patients died after enrolment
Measure: Proportion of In-hospital mortality Time: 7 daysDescription: Time to death in hours after enrolment
Measure: Time to death Time: 7 daysSecondary Outcomes
Description: Temperature in degree Fahrenheit at Day 0, 1, 3, 7
Measure: Fever Time: 7 daysDescription: Respiratory rate per minute at Day 0, 1, 3, 7
Measure: Respiratory distress Time: 7 daysDescription: Saturation of oxygen in % at Day 0, 1, 3, 7
Measure: Saturation of oxygen Time: 7 daysDescription: Blood pressure in mm of Hg at Day 0, 1, 3, 7
Measure: Blood pressure Time: 7 daysDescription: Oxygen requirements in liter/min at Day 0, 1, 3, 7
Measure: Oxygen requirement Time: 7 daysDescription: CRP level in mg/litre
Measure: C-reactive Protein Time: Day 0, 3 and 7Description: Serum Ferritin level in ng/ml
Measure: Ferritin Time: Day 0, 3 and 7Description: Serum SGPT level in I/U
Measure: SGPT Time: Day 0, 3 and 7Description: Serum SGOT level in I/U
Measure: SGOT Time: Day 0, 3 and 7Description: Duration of ICU stay in days
Measure: ICU stay Time: 14 daysDescription: Requirement of ventilator support in hours
Measure: Ventilator support Time: 14 daysDescription: Duration of hospital stay in days
Measure: Hospital stay Time: 14 daysDescription: % of patients developed early transfusion reaction like fever, sweating, rash, abdominal pain, urticaria, vomiting, wheezing, chest tightness and hypotension
Measure: Proportion of Transfusion reaction Time: 24 hours5 Convalescent Plasma Therapy in Patients With COVID-19
Scientists and medical workers all around the world were running out of time to manage COVID-19. Several studies have been done to understand the disease and ultimately to find possible treatment. Based on those studies, one of the potential treatment was antibody transfer from recovered COVID-19 patients. Passive antibody transfer was a fast and easy choice. The rational use of antibody from the patient's plasma is a natural neutralizing protein to the cell-infected virus and could possibly slow the active infection down. Investigators initiate an intervention study with purposes to produce quality convalescent plasma from the recovered patients, define the safety of plasma for human use and as an alternative treatment to improve the clinical outcomes of severe COVID-19 patients. The study hypothesis is convalescent plasma is safe and could possibly improve outcome of severe (non-critical) COVID-19 patients. This research will conduct the plaque reduction neutralizing test (PRNT) of recipient blood in vitro. The plasma will be collected in the blood transfusion unit (BTU) in Gatot Soebroto hospital. The storage, testing, transfer, and transfusion of eligible convalescent plasma are the authority of Gatot Soebroto BTU. PRNT and plasma antibody titer measurement from donor plasma will be conducted at Eijkman Institute of Molecular Biology. Investigators enroll approximately 10 patients consecutively, who will be admitted at Gatot Soebroto hospital. Baseline demographic characteristics of samples are recorded. Clinical dan laboratory data will be measured before and after plasma transfusion periodically. The measured variables are pharmacological therapy (antivirus, antibiotics, steroids), invasive oxygen therapy, oxygen index, sequential organ failure assessment (SOFA) score, and laboratory parameters such as leukocyte count, blood chemical panel include liver and renal function, C-reactive protein, procalcitonin, IL-6 and immunoglobulin titer of the recipient and also chest X-ray evaluation. The potential expected risk of plasma transfusions is transfusion reaction (immunological or non-immune related) and transferred foreign pathogen. Investigator will report and treat all adverse events after plasma transfusion has been done. A severe adverse event (SAE) will also report in a special form to sponsor and data safety monitoring board (DSMB). There is theoretically antibody-dependent enhancement (ADE) mechanism from COVID-19 whom will receive plasma transfusion to progress to severe immune response. This preliminary study is supposed to provide supporting data and experience of plasma processing to a larger study in the near future.
NCT04407208 Convalescence Corona Virus Infection Plaque Biological: Convalescent plasma MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Convalescence
Primary Outcomes
Description: PNRT50
Measure: Plaque reduction neutralization test (PNRT) Time: day 7 after first transfusionDescription: Change of D-dimer compared between pre and post transfusion
Measure: D-dimer Time: day 1,4,7,14 after first transfusionDescription: Change of CRP compared between pre and post transfusion
Measure: C-Reactive Protein (CRP) Time: day 1,4,7,14 after first transfusionDescription: Change of INR compared between pre and post transfusion
Measure: International Normalized Ratio (INR) Time: day 1,4,7,14 after first transfusionDescription: Change of OI compared between pre and post transfusion
Measure: Oxygenation Index Time: day 1,4,7,14 after first transfusionDescription: Change of CXR with CXR covid score compared between pre and post transfusion
Measure: Chest X-ray Time: day 1,4,7,28 after first transfusionSecondary Outcomes
Description: every adverse event that cause patient to die, prolonged hospitalization or worsening clinical stage of illness
Measure: severe adverse event Time: from day 0 to 14 days after plasma transfusion