Covid 19 Clinical Trials

	Name (Synonyms)	Correlation
D007565	Jaundice, NIH	0.41
D002761	Cholangitis NIH	0.41
D018281	Cholangiocarcinoma NIH	0.41
D059350	Chronic Pain NIH	0.41
D006819	Hyaline Membrane Disease NIH	0.41
D008105	Liver Cirrhosis, Biliary NIH	0.41
D010190	Pancreatic Neoplasms NIH	0.41
D002647	Chilblains NIH	0.41
D041781	Jaundice, Obstructive NIH	0.41
D013577	Syndrome NIH	0.05
D012127	Respiratory Distress Syndrome, Newborn NIH	0.05
D045169	Severe Acute Respiratory Syndrome NIH	0.05
D012128	Respiratory Distress Syndrome, Adult NIH	0.05
D018352	Coronavirus Infections NIH	0.04

Correlated HPO Terms (6)

	Name (Synonyms)	Correlation
HP:0002613	Biliary cirrhosis HPO	0.41
HP:0002894	Neoplasm of the pancreas HPO	0.41
HP:0000952	Jaundice HPO	0.41
HP:0030151	Cholangitis HPO	0.41
HP:0012532	Chronic pain HPO	0.41
HP:0030153	Cholangiocarcinoma HPO	0.41

There are 6 clinical trials

Clinical Trials

1 Anti-MERS-COV Convalescent Plasma Therapy

Since the first report of the Middle East Respiratory Syndrome Corona virus (MERS- CoV) in September 2012, more than 800 cases have been reported to the World Health Organization (WHO) with substantial mortality.

NCT02190799 Respiratory Distress Syndrome ( Respiratory Distress Syndrome (& Respiratory Distress Syndrome (& [Hyaline Membrane Disease Respiratory Distress Syndrome (& [Hyaline Membrane Disease] Respiratory Distress Syndrome (& [Hyaline Membrane Disease]) Biological: Convalescent plasma

MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Hyaline Membrane Disease

Primary Outcomes

Description: Hospital mortality will be death in the ICU during the same hospital admission

Measure: Hospital mortality

Time: Death in the Hospital (ICU or ward) before or at 6 months after enrollment

Secondary Outcomes

Description: Death in the ICU during the same hospital admission.

Measure: ICU mortality

Time: Death in the ICU at or after 90 days of enrollment

Description: Number of calendar days between admission and final discharge from ICU.

Measure: ICU Length of Stay

Time: Number of days in ICU with an average expected duration of 10 days.

Description: Number of calendar days between start and final liberation from mechanical ventilation.

Measure: Duration of Mechanical Ventilation

Time: Number of days of mechanical ventilation with an expected average duration of 8 days

Description: viral clearance from all sampled sites by day 3 after administration of CP

Measure: Viral load in tracheal aspirate

Time: Serial levels in the first 28 days of enrollment

Description: Epidermal Growth Factor (EGF), Eotaxin, Granulocyte colony-stimulating factor (G-CSF), Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Interferon(IFN)-γ, IFN-a2, Interleukin (IL)-10, IL-12(p40), IL-12(p70), IL-13, IL-15, IL-17, IL-1ra, IL-1a, IL-1β, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, Interferon gamma-induced protein (IP)-10, Monocyte Chemotactic Protein (MCP)-1, Macrophage Inflammatory Protein (MIP)-1a, MIP-1β, Tumor Necrosis Factor-α (TNF-a), TNF-β, Vascular Endothelial Growth Factor (VEGF)

Measure: Inflammatory markers,

Time: Serial levels in the first 28 days of enrollment

Description: anti-MERS-CoV antibody level before and after administration of CP.

Measure: Anti-MERS-CoV antibodies

Time: Serial levels in the first 28 days of enrollment

Other Outcomes

Description: X ray changes at day 0, 1, 3, 7, 14, 21 and 28

Measure: Chest X ray

Time: Serial changes in the X ray till day 28

2 Convalescent Plasma Therapy From Recovered Covid-19 Patients as Therapy for Hospitalized Patients With Covid-19

Passive immunization with immunoglobulins is occasionally used as therapy for the treatment of viral infectious diseases. Immunoglobulins are used for the treatment of CMV disease, and is effective as prophylaxis when given soon after exposure to varicella zoster virus, rabies, and hepatitis B virus. Neutralizing antibodies against MERS, SARS-CoV-1 and SARS-CoV-2 have been shown to be present in patients previously infected with MERS, SARS-CoV-1 and SARS-CoV-2 respectively. During the 2003 SARS outbreak in Hong-Kong,a non-randomized study in hospitalized SARS patients showed that treatment with convalescent plasma (convP) from SARS-recovered donors significantly increased the day 22 discharge rate and decreased mortality. A study in non-human primates showed that rhesus macaques could not be re-infected with SARS-CoV-2 after primary infection. With no proven effective therapy against COVID, this study will evaluate the safety and efficacy of convalescent plasma from COVID-recovered donors as a treatment for hospitalized patients with symptomatic COVID-19. The study will focus on patients who tested positive for SARS-CoV-2 in the last 96 hours before inclusion Primary objectives • Decrease overall mortality in patients within COVID disease Study design: This trial is a randomized comparative trial. Patients will be randomized between the infusion of 300mL of convP with standard of care. Patient population: Patients with PCR confirmed COVID disease, age >18 years Donors will be included with a known history of COVID who have been asymptomatic for at least 14 days. Intervention: 300mL of convP Duration of treatment: ConvP will be given as a one-time infusion Duration of follow up: For the primary endpoint: until discharge or death before day 60, whichever comes first. For the secondary endpoints (with separate consent) up to 1 year. Target number of patients: 426 Target number of donors: 100 Expected duration of accrural: 36 months

NCT04342182 COVID-19 Biological: Convalescent plasma

Primary Outcomes

Description: the mortality in the 300ml convP group will be compared with the control arm

Measure: Overall mortality until discharge from the hospital or a maximum of 60 days after admission whichever comes first

Time: until hospital discharge or a maximum of 60 days whichever comes first

Secondary Outcomes

Description: the hospital days in the 300ml convP group will be compared with the control arm

Measure: Impact of 300ml convP therapy on hospital days

Time: until hospital discharge or a maximum of 60 days whichever comes first

Description: A patient will be considered weaned from oxygen therapy when the patient did not receive oxygen for at least 24 hours.

Measure: Impact of 300ml convP on weaning from oxygen therapy

Time: until hospital discharge or a maximum of 60 days whichever comes first

Description: the overall mortality in hospital days in patients admitted tot the ICU within 24 hours after admission in the 300ml convP group will be compared with the patients admitted tot the ICU within 24 hours after admission in the control arm

Measure: Impact of 300ml convP on overall mortality in patients admitted to the ICU within 24 hours after admission

Time: until hospital discharge or a maximum of 60 days whichever comes first

Description: The mortality in patients with a duration of symptoms less than the median duration of symptoms in the study population will be compared with the mortality in patients with a duration of symptoms more than the median duration of symptoms in the study population

Measure: Difference in the effect of convP on mortality in patients with a duration of symptoms less or more the median duration of symptoms in the study population

Time: hospital discharge or a maximum of 60 days whichever comes first

Description: the ICU days in hospital days in patients admitted to the ICU within 24 hours after admission in the 300ml convP group will be compared with the patients admitted tot the ICU within 24 hours after admission in the control arm

Measure: Impact of 300ml convP therapy on ICU days in patients admitted to the ICU within 24 hours after admission

Time: Until hospital discharge, estimated average 4 weeks

Description: airway samples will be taken on day 1 - 3 - 5 - 7 - 10 - 14 - and at discharge

Measure: Impact of plasma therapy on the decrease in SARS-CoV2 shedding from airways

Time: until hospital discharge, estimated average 2 weeks

Description: Blood wil be drawn at day 1, day 7 and day 14

Measure: Impact of CTL and NK cell immunity on the likelihood of being protected from immune serum transfer

Time: until hospital discharge, extimated average 2 weeks

Description: Evaluation of Severe Adverse Events and transfusion related adverse events

Measure: Safety of convP therapy

Time: until hospital discharge or a maximum of 60 days whichever comes first

Description: The WHO COVID19 disease severity scale on day 15 will be compared with the WHO COVID19 disease severity scale on day 1

Measure: Change of the 8-point WHO COVID19 disease severity scale on day 15

Time: until day 15

Description: The WHO COVID19 disease severity scale on day 30 will be compared with the WHO COVID19 disease severity scale on day 1 and day 15

Measure: Change of the 8-point WHO COVID19 disease severity scale on day 30

Time: until day 30

Description: The WHO COVID19 disease severity scale on day 15 will be compared with the WHO COVID19 disease severity scale on day 1 in patients with a baseline neutralizing antibody titer (PRNT50) <80.

Measure: Change of the 8-point WHO COVID19 disease severity scale on day 15 in the subgroup of patients with a baseline neutralizing antibody titer (PRNT50) <80.

Time: until day 15

Description: Low dose CT and lung function is done 6 weeks after discharge and if abnormal again 3 months after discharge.

Measure: Impact of plasma therapy on risk of long-term structural lung damage and lung function

Time: up to 12 months after plasma transfusion

3 A Randomized Open-Label Trial of CONvalenscent Plasma for Hospitalized Adults With Acute COVID-19 Respiratory Illness (CONCOR-1)

There is currently no treatment available for COVID-19, the acute respiratory illness caused by the novel SAR-CoV-2. Convalescent plasma from patients who have recovered from COVID-19 that contains antibodies to the virus is a potential therapy. On March 25th, 2020, the FDA approved the use of convalescent plasma under the emergency investigational new drug (eIND) category. Randomized trials are needed to determine the efficacy and safety of COVID-19 convalescent plasma for acute COVID-19 infection. The objective of the CONCOR-1 trial is to determine the efficacy of transfusion of COVID-19 convalescent plasma to adult patients admitted to hospital with COVID-19 infection at decreasing the frequency of in-hospital mortality in patients hospitalized for COVID-19. It is hypothesized that treating hospitalized COVID-19 patients with convalescent plasma early in their clinical course will reduce the risk of death, and that other outcomes will be improved including risk of intubation, and length of ICU and hospital stay. This pan-Canadian clinical trial has the potential to improve patient outcomes and reduce the burden on health care resources including reducing the need for ICU beds and ventilators.

NCT04348656 COVID-19 Other: Convalescent plasma

Primary Outcomes

Description: Endpoint of the need for intubation or patient death in hospital

Measure: Intubation or death in hospital

Time: Day 30

Secondary Outcomes

Description: Endpoint of the need for intubation before 30 days

Measure: Need for Intubation

Time: Day 30

Description: Time in hours to intubation from randomization

Measure: Time to intubation

Time: Day 30

Description: Endpoint of the number of days off ventilator at 30 days

Measure: Ventilator-free days

Time: Day 30

Description: In-hospital death censored at 90 days

Measure: In-hospital death

Time: 90 days

Description: Time to in-hospital death at 90 days

Measure: Time to in-hospital death

Time: Day 90

Description: Death at 30 days

Measure: Death at 30 days

Time: 30 days

Description: Date of intensive care unit admission (first date and total number of days)

Measure: Length of stay in intensive care unit (ICU)

Time: Day 30

Description: Date of hospital admission (first date and total number of days)

Measure: Length of stay in hospital

Time: Day 30

Description: First date on ECMO and total number of days

Measure: Need for extracorpeal membrane oxygenation (ECMO)

Time: Day 30

Description: Need for renal replacement therapy

Measure: Need for renal replacement therapy

Time: Day 30

Description: New myocarditis

Measure: Development of myocarditis

Time: Day 30

Description: Transfusion-associated adverse events, Grade 3 and 4 serious adverse events, and cumulative incidence of Grade 3 and 4 adverse events and serious adverse events (using medDRA)

Measure: Adverse events and serious adverse events

Time: Day 30

Description: CCP transfusion-associated adverse events (AE)

Measure: CCP transfusion-associated adverse events (AE)

Time: 30 days

4 COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma

COVID-19 disease has become a very serious global health problem. Treatments for severe forms are urgently needed to lower mortality. Any procedure that improves these forms should be considered, especially those devoid of serious side effects.There is not enough published information on the use of allogeneic convalescent plasma (ACP) in the treatment of severe forms of COVID-19. The use of ACP can be combined with other treatments and has very few adverse effects. It takes 10-14 days for SARS-CoV2-infected patients to produce virus-neutralizing antibodies: within that time they can develop serious complications and die. Injecting PAC into patients with severe forms of COVID-19 shortens the period of risk while the patient produces the antibodies.

NCT04357106 COVID-19 Biological: Convalescent plasma

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: PaO2/FiO2 relation

Measure: Lung injury

Time: 7 days

Description: Patients survival after therapy

Measure: Overall survival

Time: 15-30 days

Secondary Outcomes

Description: Determine the incidence of side effects from plasma administration

Measure: Adverse reactions to plasma

Time: 7 days

5 The Use of Convalescent Plasma for Patients Hospitalized With COVID-19 Disease

Pilot study of tolerability and efficacy of transfusion of 200mL of convalescent plasma in patients with COVID-19 respiratory disease.