CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D005355: Fibrosis NIH

(Synonyms: Fibrosi, Fibrosis)

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


Correlated Drug Terms (9)


Name (Synonyms) Correlation
drug433 CFTR Modulators Wiki 0.45
drug1543 N-acetylcysteine+Placebo Wiki 0.45
drug2601 Unsupervised exercise Wiki 0.45
drug1542 N-acetylcysteine+ Fuzheng Huayu Tablet Wiki 0.45
drug869 Esomeprazole 20mg Wiki 0.45
drug880 Exercise Wiki 0.32
drug1243 Interview Wiki 0.26
drug1978 Questionnaire Wiki 0.09
drug1822 Placebo Wiki 0.03

Correlated MeSH Terms (3)


Name (Synonyms) Correlation
D003550 Cystic Fibrosis NIH 0.52
D008103 Liver Cirrhosis, NIH 0.45
D011658 Pulmonary Fibrosis NIH 0.20

Correlated HPO Terms (2)


Name (Synonyms) Correlation
HP:0001395 Hepatic fibrosis HPO 0.45
HP:0002206 Pulmonary fibrosis HPO 0.20

There are 5 clinical trials

Clinical Trials


1 A Randomized, Placebo-Controlled, Multi-Center Study on the Efficacy and Safety of Fuzheng Huayu on Pulmonary Fibrosis Due to 2019-nCoV

Inflammation is the early stage of fibrosis. Serious patients are more likely to develop into pulmonary fibrosis, which affects the recurrence of lung function or even threatens life and health. This study is planned to observe the efficacy and safety of Fuzheng Huayu tablets in the treatment of pulmonary fibrosis after COVID-19.

NCT04279197 Pulmonary Fibrosis Due to 2019-nCoV Drug: N-acetylcysteine+ Fuzheng Huayu Tablet Drug: N-acetylcysteine+Placebo
MeSH:Pulmonary Fibrosis Fibrosis
HPO:Pulmonary fibrosis

Primary Outcomes

Description: Evaluation of Pulmonary fibrosis Improvement. HRCT images are graded from 1 to 6, higher scores mean a worse outcome.

Measure: High-resolution computed tomography (HRCT) score

Time: Week 24

Description: Evaluation of Lung Function Improvement

Measure: Lung function including FVC, FVC as a percentage of projected value and DLco

Time: Week 24

Secondary Outcomes

Description: Times of acute exacerbations during treatment

Measure: Times of acute exacerbation

Time: Week 24

Description: Measured by a 6-minute walking test

Measure: Six-minute walk distance

Time: Week 24

Description: Using the scale revised by British modified Medical Research Council (MMRC) which divided patients into five degrees.Higher scores mean a worse outcome.

Measure: Dyspnea Scores

Time: Week 24

Description: Evaluation of Pulmonary fibrosis Improvement on CT which is calculated by formula.

Measure: Composite physiological index

Time: Week 24

2 Clinical Characteristics of COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational Study

COVID-19 pandemic with SARS-CoV-2 infection has become a global challenge. Though most cases of COVID-19 are mild, the disease can also be fatal. Patients with liver cirrhosis are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. The spectrum of disease and factors that influence the disease course in COVID-19 cases with liver cirrhosis are incompletely defined. This muilticentre observational study (COVID-Cirrhosis-CHESS2002) aims to study the clinical characteristics and risk factors associated with specific outcomes in COVID-19 patients with pre-existing liver cirrhosis.

NCT04329559 COVID-19 Liver Cirrhosis
MeSH:Liver Cirrhosis Fibrosis
HPO:Cirrhosis Hepatic fibrosis

Primary Outcomes

Description: 7-day, 28-day, 60-day, 180-day and 365-day all-cause mortality of COVID-19 patients with liver cirrhosis

Measure: All-cause mortality of COVID-19 patients with liver cirrhosis

Time: From illness onset of COVID-19 to death from any cause, up to 365 days

Secondary Outcomes

Description: 7-day, 28-day, 60-day, 180-day and 365-day liver-related mortality of COVID-19 patients with liver cirrhosis

Measure: Liver-related mortality of COVID-19 patients with liver cirrhosis

Time: From illness onset of COVID-19 to death from liver-related cause, up to 365 days

Description: Risk factors (laboratory findings, imaging findings, etc.) associated with specific outcomes (death, etc.) of COVID-19 patients with liver cirrhosis

Measure: Risk factors associated with specific outcomes of COVID-19 patients with liver cirrhosis

Time: From hospital admission to death, up to 365 days

Description: Baseline characteristics (laboratory findings, imaging findings, etc.) of COVID-19 patients with liver cirrhosis

Measure: Baseline characteristics of COVID-19 patients with liver cirrhosis

Time: 1 Day

3 Combined Effect of CFTR Protein Modulator Drugs and Exercise on Pulmonary Function, Fitness, Sweat Test and Quality of Life in Children With Cystic Fibrosis

This study aims to assess the effects of programmed exercise combined with CFTR protein modulator drugs in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis.

NCT04415268 Cystic Fibrosis in Children Behavioral: Exercise Behavioral: Unsupervised exercise Drug: CFTR Modulators
MeSH:Cystic Fibrosis Fibrosis

Primary Outcomes

Description: Changes in strength will be measured using a five repetition maximum test (5RM)

Measure: Change in Strength

Time: Four assessment points throughout the study: baseline and after each 8-week intervention

Description: Changes in cardiorespiratory fitness will be measured using a cardiopulmonary exercise test (CPET)

Measure: Change in Cardiorespiratory Fitness

Time: Four assessment points throughout the study: baseline and after each 8-week intervention

Secondary Outcomes

Description: Changes in FEV1 will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)

Measure: Changes in Forced expiratory volume in 1 second (FEV1)

Time: Four assessment points throughout the study: baseline and after each 8-week intervention

Description: Changes in FVC will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)

Measure: Changes in Forced vital capacity (FVC)

Time: Four assessment points throughout the study: baseline and after each 8-week intervention

Description: Changes in FEV1/FVC ratio (FEV1%) will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)

Measure: Changes in FEV1/FVC ratio (FEV1%)

Time: Four assessment points throughout the study: baseline and after each 8-week intervention

Description: Changes in FEF will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)

Measure: Changes in Forced expiratory flow (FEF)

Time: Four assessment points throughout the study: baseline and after each 8-week intervention

Description: Changes in physical activity levels will be measured using PAQ-C for children under 14 years of age and PAQ-A for adolescents over 14 years of age. Items 1 to 9 will be used in the physical activity composite score, and means will be calculated to obtain the final PAQ-C activity summary score. Items 1 to 8 will be used in the physical activity composite score, and means will be calculated to obtain the final PAQ-A activity summary score. A score of 1 indicates low physical activity, whereas a score of 5 indicates high physical activity.

Measure: Changes in Physical Activity Questionnaire (PAQ) for children and adolescents

Time: Four assessment points throughout the study: baseline and after each 8-week intervention

Description: Changes in quality of life will be measures with the Cystic Fibrosis-Questionnaire-Revised (CFQ-R). Scores for each health related quality of life domain are calculated; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health.

Measure: Change in quality of life: Cystic Fibrosis-Questionnaire-Revised (CFQ-R)

Time: Four assessment points throughout the study: baseline and after each 8-week intervention

Description: Chloride concentration in sweat (mEq/L) will be measured in the laboratory using an MK II Chloride Analyzer 926S

Measure: Sweat chloride level

Time: Four assessment points throughout the study: baseline and after each 8-week intervention

4 Stop of Proton-pump Inhibitor Treatment in Patients With Liver Cirrhosis - a Double-blind, Placebo-controlled Trial

Proton-pump inhibitors (PPI) are commonly prescribed in an uncritical manner to patients with liver cirrhosis without a clear evidence-based indication. Observational studies suggests that PPI use in cirrhotic patients may be a risk factor for the development of infections, especially spontaneous bacterial peritonitis (SBP). A possible explanation are PPI-associated microbiotic shifts leading to small intestinal bacterial overgrowth with subsequently increased bacterial translocation. Furthermore, PPI therapy in cirrhotic patients may lead to an increased risk for pneumonia and Clostridium difficile-infections. However, the evidence is ambiguous, as other published studies found no evidence for an association of PPI use with an increased risk for SBP or pneumonia. Moreover, an association between episodes of hepatic encephalopathy and PPI use has been reported. Infections and hepatic encephalopathy may often lead to a hospitalization of cirrhotic patients and PPI use at discharge has also been associated to early re-hospitalization. While some studies found an association of PPI and increased mortality in cirrhotic patients, other studies could not observe this association. Thus, some of the current evidence suggests an unfavourable risk profile of PPIs in patients with liver cirrhosis. However, this patient population is considered to be at a high risk of gastrointestinal haemorrhage from peptic ulcers. Importantly, patients with liver cirrhosis have an increased mortality after peptic ulcer bleeding as compared to patients without cirrhosis. Therefore, generous PPI use may also have a yet unproven preventive effect against upper gastrointestinal bleeding. The STOPPIT trial is the first prospective, randomized, controlled, double-blind trial investigating the effect of discontinuation of long-term PPI therapy on hospitalized patients with complicated liver cirrhosis with a pre-existing long-term PPI therapy. Importantly, patients with an evidence-based indication for PPI therapy are excluded from the trial. All study participants (n=476) stop their previous PPI treatment and are then randomized (1:1) to receive either placebo (intervention group) or esomeprazole 20mg/day (control group) for 360 days. The primary hypothesis anticipates a delay of re-hospitalisation and/or death (composite endpoint) in patients who discontinue PPI treatment as compared to patients who continue PPI therapy. Secondary objectives include the assessment of mortality, re-hospitalisation rates, infection rates, rate of acute hepatic decompensation and ACLF, as well as rates of upper and lower gastrointestinal bleeding events in both groups. Impact of prolonged or discontinued PPI therapy on the intestinal microbiota and pharmacoeconomics will be studied as a secondary assessment.

NCT04448028 Liver Cirrhosis Drug: Placebo Drug: Esomeprazole 20mg
MeSH:Liver Cirrhosis Fibrosis
HPO:Cirrhosis Hepatic fibrosis

Primary Outcomes

Measure: Timepoint of first unplanned re-hospitalization or death (whichever occurs first)

Time: Within 12 months (360 days) after randomization

Secondary Outcomes

Measure: Timepoint of death

Time: Within 12 months (360 days) after randomization

Measure: Mortality rate

Time: 360 days after randomization

Measure: Timepoint of first unplanned re-hospitalization

Time: Within 12 months (360 days) after randomization

Measure: Rate of unplanned re-hospitalizations

Time: 360 days after randomization

Measure: Overall infection rate

Time: 360 days after randomization

Description: Infection rates by site of infection (SBP, pneumonia, urinary tract infection, blood stream infection, Clostridium difficile-associated enterocolitis, Norovirus-infection, Sars-CoV-2-infection)

Measure: Infection rates differentiated by site

Time: 360 days after randomization

Measure: Rate of acute decompensation of liver cirrhosis

Time: 360 days after randomization

Measure: Rate of acute-on-chronic liver failure (ACLF)

Time: 360 days after randomization

Measure: Rate of upper gastrointestinal bleeding events

Time: 360 days after randomization

Measure: Rate of lower gastrointestinal bleeding events

Time: 360 days after randomization

Description: The gut microbiota composition will be analyzed by PCR

Measure: Changes of intestinal microbiota between baseline and day 90

Time: 90 days after randomization

Other Outcomes

Measure: Rate of occurence of the safety endpoint (evidence-based indication for open-label re-therapy with PPIs)

Time: 360 days after randomization

Measure: Rate of any (serious) adverse events

Time: 360 days after randomization

5 Impacts of the Covid-19 Epidemic and Associated Lockdown Measures on the Management, Health and Behaviors of Cystic Fibrosis Patients During the 2020 Epidemic

Impacts of the Covid-19 epidemic and associated lockdown measures on the management, health and behaviors of cystic fibrosis patients during the 2020 epidemic

NCT04463628 Cystic Fibrosis in Children Cystic Fibrosis Behavioral: Questionnaire Behavioral: Interview
MeSH:Cystic Fibrosis Fibrosis

Primary Outcomes

Description: Number of consultations cancelled or postponed by the health professional or patient of consultations (medical and paramedical),

Measure: Cancellation or postponement of consultations by the health professional or patient,

Time: Up to 6 months

Description: Number of consultations cancelled by the teleconsultation/replacement patient,

Measure: Patient cancellation of teleconsultations/telecare replacement,

Time: Up to 6 months

Description: Number of consultations cancelled or postponed by the health care institution or by the patient of hospitalizations (acute or scheduled)

Measure: Cancellation or postponement by the health care institution or by the patient of hospitalizations (scheduled or unscheduled),

Time: Up to 6 months

Description: Number of patients affected by the change in the modality of administration of antibiotic cures (intravenous instead of intravenous administration).

Measure: Change in the modalities of administration of antibiotics cures (oral instead of intravenous administration).

Time: Up to 6 months

Secondary Outcomes

Description: Cancellation or postponement by the patient of consultations (medical or paramedical) Patient cancellation of teleconsultations/telecare proposed by the health professional Cancellation or postponement by the patient of hospitalizations (acute or scheduled)

Measure: The reduction of each of the elements of care provision and health care utilization:

Time: Up to 6 months

Description: Intravenous instead of intravenous administration

Measure: The change of modality of administration of antibiotic cures

Time: Up to 6 months

Description: Questionnaire about taking or not taking treatment during confinement

Measure: Compliance

Time: Up to 6 months

Description: Scale 0-21

Measure: Anxiety and stress (at risk of being affected by COVID-19 or at risk of being treated less well)

Time: Up to 6 months

Description: A questionnaire on the presence or absence of toxic consumption

Measure: Presence or absence of toxic consumption (drug, alcohol) during the lockdown

Time: Up to 6 months

Description: Experience and social representations of confinement by cystic fibrosis patients (evaluated by qualitative methods)

Measure: Evaluation of the knowledge, experience and social representations of the risk of Covid-19

Time: Up to 6 months

Description: Role of social inequalities in the consequences of containment assessed by qualitative methods

Measure: Assessing the role of social inequalities in the consequences of lockdown

Time: Up to 6 months

Description: Prevalence of suspected and/or confirmed Covid-19 infections in patients with cystic fibrosis

Measure: Suspected and/or confirmed Covid-19 in patients with cystic fibrosis.

Time: Up to 6 months


HPO Nodes