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D003289: Convalescence

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (18)


Name (Synonyms) Correlation
drug1557 Hydroxychloroquine in combination of Azithromycin Wiki 0.45
drug1555 Hydroxychloroquine as post exposure prophylaxis Wiki 0.45
drug255 Anti- SARS-CoV-2 Plasma Wiki 0.45
Name (Synonyms) Correlation
drug1750 Ivermectin 3mg Tab Wiki 0.45
drug2354 Others(No intervention) Wiki 0.45
drug1558 Hydroxychloroquine plus Nitazoxanide Wiki 0.45
drug3850 conventional management of patients Wiki 0.45
drug3908 hydroxychloroquine in combination with camostat mesylate Wiki 0.45
drug2957 SARS-CoV-2 non-immune Plasma Wiki 0.45
drug1553 Hydroxychloroquine and azithromycin treatment Wiki 0.45
drug2094 Moxibustion plus Cupping Wiki 0.45
drug1550 Hydroxychloroquine Sulfate Tablets Wiki 0.32
drug2606 Povidone-Iodine Wiki 0.22
drug3847 convalescent plasma Wiki 0.20
drug908 Convalescent plasma Wiki 0.20
drug3749 Zinc Wiki 0.16
drug3212 Standard care Wiki 0.16
drug3674 Vitamin C Wiki 0.12

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.03
D045169 Severe Acute Respiratory Syndrome NIH 0.02

Correlated HPO Terms (0)


Name (Synonyms) Correlation

Clinical Trials

Navigate: Correlations   HPO

There are 5 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
Conditions
  1. Coronavirus
  2. Convalescence
Interventions
  1. Biological: Anti- SARS-CoV-2 Plasma
  2. 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 28

Description: 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 28

Description: 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 28

Secondary 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 28

Other 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 0

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.

Measure: Anti-SARS-CoV-2 titers Day 1

Time: Day 1

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 7.

Measure: Anti-SARS-CoV-2 titers Day 7

Time: Day 7

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 14.

Measure: Anti-SARS-CoV-2 titers Day 14

Time: Day 14

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 90.

Measure: Anti-SARS-CoV-2 titers Day 90

Time: Day 90

Description: 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 28

Description: 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 28

Description: 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 28
2 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
Conditions
  1. COVID-19
  2. SARS-CoV 2
  3. Convalescence
  4. Plasma
  5. Doses
Interventions
  1. 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 +22

Description: 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 +12

Description: 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 +12

Description: 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 +30

Secondary Outcomes

Description: days of stay at ICU will be evaluated

Measure: days at ICU

Time: day 0 to day +30
3 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
Conditions
  1. COVID-19
  2. Convalescence
Interventions
  1. 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 4

Secondary 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 8

Description: 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 8

Description: 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 8

Description: 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 8

Description: 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 8

Description: 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 8

Description: 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 8

Description: 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 8

Description: 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 4

Description: Lung CT shows complete absorption of inflammation.

Measure: The proportion of patients whose lung CT return to normal on week 4

Time: week 4

Description: 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 8

Description: 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 8

Description: 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 8

Description: 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 4

Description: 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 4

Description: 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 4

Description: 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 4

Description: 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 4

Description: 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 4
4 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
Conditions
  1. Covid19
  2. Convalescence
Interventions
  1. Biological: Convalescent plasma
MeSH:Convalescence

Primary Outcomes

Description: % of patients died after enrolment

Measure: Proportion of In-hospital mortality

Time: 7 days

Description: Time to death in hours after enrolment

Measure: Time to death

Time: 7 days

Secondary Outcomes

Description: Temperature in degree Fahrenheit at Day 0, 1, 3, 7

Measure: Fever

Time: 7 days

Description: Respiratory rate per minute at Day 0, 1, 3, 7

Measure: Respiratory distress

Time: 7 days

Description: Saturation of oxygen in % at Day 0, 1, 3, 7

Measure: Saturation of oxygen

Time: 7 days

Description: Blood pressure in mm of Hg at Day 0, 1, 3, 7

Measure: Blood pressure

Time: 7 days

Description: Oxygen requirements in liter/min at Day 0, 1, 3, 7

Measure: Oxygen requirement

Time: 7 days

Description: CRP level in mg/litre

Measure: C-reactive Protein

Time: Day 0, 3 and 7

Description: Serum Ferritin level in ng/ml

Measure: Ferritin

Time: Day 0, 3 and 7

Description: Serum SGPT level in I/U

Measure: SGPT

Time: Day 0, 3 and 7

Description: Serum SGOT level in I/U

Measure: SGOT

Time: Day 0, 3 and 7

Description: Duration of ICU stay in days

Measure: ICU stay

Time: 14 days

Description: Requirement of ventilator support in hours

Measure: Ventilator support

Time: 14 days

Description: Duration of hospital stay in days

Measure: Hospital stay

Time: 14 days

Description: % 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 hours
5 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
Conditions
  1. Convalescence
  2. Corona Virus Infection
  3. Plaque
Interventions
  1. 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 transfusion

Description: Change of D-dimer compared between pre and post transfusion

Measure: D-dimer

Time: day 1,4,7,14 after first transfusion

Description: Change of CRP compared between pre and post transfusion

Measure: C-Reactive Protein (CRP)

Time: day 1,4,7,14 after first transfusion

Description: Change of INR compared between pre and post transfusion

Measure: International Normalized Ratio (INR)

Time: day 1,4,7,14 after first transfusion

Description: Change of OI compared between pre and post transfusion

Measure: Oxygenation Index

Time: day 1,4,7,14 after first transfusion

Description: 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 transfusion

Secondary 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

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook