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NCT ID: NCT04880642 Completed - COVID-19 Clinical Trials

A Trial to Investigate Recovery From COVID-19 With C21 in Adult Subjects

ATTRACT-3
Start date: September 16, 2021
Phase: Phase 3
Study type: Interventional

This trial is a randomized, double-blind, placebo-controlled, parallel-group, 2-arm, multicenter trial to evaluate the efficacy and safety of C21 versus placebo as add-on to standard of care (SoC) in adult subjects with COVID-19. The trial planned to enroll a total of maximum 300 randomized subjects, 150 per arm (oral C21 100 mg twice a day (BID) or placebo for 14 days) according to the 1:1 randomization.

NCT ID: NCT04862741 Completed - Ulcerative Colitis Clinical Trials

Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis

Start date: May 5, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1b, randomized, double-blind, multicenter dose-ranging study to evaluate the safety, tolerability, and PK of NX-13. Approximately 40 subjects will be randomized in a 3:3:3:1 ratio to receive 1 of 3 NX-13 treatment regimens (NX-13 250 mg IR, 500 mg IR, 500 mg MR) (12 evaluable subjects at each of the 3 dose levels) or placebo (4 subjects), once daily for 28 consecutive days.

NCT ID: NCT04836559 Completed - Clinical trials for Focal Onset Seizures

A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy

Start date: May 18, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of up to 3 dose levels of adjunctive JNJ-40411813 compared to placebo based on the time to baseline monthly seizure count in participants with focal onset seizures who are receiving levetiracetam or brivaracetam and up to 3 other anti-epileptic drugs (AEDs) (double-blind treatment period) and to evaluate the long-term efficacy and safety of adjunctive therapy with JNJ-40411813 in participants with epilepsy (open-label extension [OLE] period).

NCT ID: NCT04797936 Completed - Covid19 Clinical Trials

BNO 1030 Extract (Imupret) in the Treatment of Mild Forms of COVID-19

Start date: May 1, 2020
Phase: Phase 4
Study type: Interventional

According to WHO (World Health Organisation) data, about 40% of patients with COVID-19 (Corona Virus SARS-CoV-2) have a mild course of the disease, namely, cases of mild course are of great danger from the point of view of the spread of infection, since the main source of infection is a sick person. The mild course of COVID-19 is characterized by a number of nonspecific symptoms: fever, cough, sore throat, nasal congestion, malaise, headache, muscle pain. Evidence has emerged of loss of smell as a symptom of COVID-19 infection. Anosmia/hyposmia in the absence of other respiratory diseases, such as allergic rhinitis, acute rhinosinusitis, or chronic rhinosinusitis, are considered as a clinical marker of COVID-19 infection in a pandemic.For people with a mild course of the disease, WHO recommends providing home care, and the recommendations come down to observing a sanitary-hygienic regimen and taking antipyretics if necessary. Unfortunately, the treatment of patients with a mild course is still outside the interest of medical science. In its updated strategy to curb the spread of COVID-19, WHO states the need for diagnosis, effective isolation, and treatment of patients with mild to moderate severity of the clinical course of patients.Currently, there is experience with the use of the drug Imupret for the treatment of nasopharyngitis associated with other viral pathogens, in particular Epstein-Barr virus. It was shown that the use of a Phyto preparation helps to accelerate the regression of symptoms characteristic of nasopharyngitis, as well as accelerate the elimination of the virus from the body. Obviously, the proven activity of Imupret is important in relation to the activation of factors of nonspecific immunity, which is important in confronting viruses, including COVID-19. Another obvious factor that is important for the treatment of viral diseases is the synergism of the active substances in oak bark and walnut leaves with respect to inhibition of reverse transcriptase of a wide range of respiratory viruses, as well as the anti-inflammatory effect of the drug. Confirmation of the therapeutic effect of Imupret for the treatment of nasopharyngitis associated with COVID-19 would allow the development of new therapeutic tools to combat this infection and put into practice updated WHO emphasis on national health systems: it is important to identify, treat and isolate all cases of COVID-19, including cases with mild or moderate severity of the disease.

NCT ID: NCT04781816 Completed - Clinical trials for Cutaneous Lupus Erythematosus

Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus

CLEan
Start date: April 1, 2021
Phase: Phase 2
Study type: Interventional

Primary Objective: - Assess the efficacy of SAR443122 in cutaneous lupus erythematosus (CLE) Secondary Objectives: - Assess the effect of SAR443122 on the physician's global assessment of disease activity (PhysGA - disease activity) - Assess the effect of SAR443122 on CLE induced itch and overall pain - Assess the effect of SAR443122 on the proportion of disease activity responders compared to placebo - Assess the effect of SAR443122 on the CLASI components score - Assess the effect of SAR443122 on the Investigator's global assessment for CLE (IGA-CLE) - Assess oral cavities for patients with oral lesions - Assess the disease specific quality of life (QoL) - Assess the safety and tolerability of SAR443122 in patients with CLE - Assess the pharmacokinetics (PK) exposure of SAR443122 in patients with CLE

NCT ID: NCT04770532 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Use Daily Insulin

ONWARDS 2
Start date: March 5, 2021
Phase: Phase 3
Study type: Interventional

This study compares insulin icodec (a new insulin taken once a week) to insulin degludec (an insulin taken once daily which is already available on the market) in people with type 2 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily. Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week or insulin degludec that participants will have to inject once a day at the same time every day. Which treatment participants get is decided by chance. The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The study will last for about 8 months. Participants will have 17 clinic visits and 13 phone calls with the study doctor. At 8 clinic visits participants will have blood samples taken. At 4 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Participants will be asked to wear a sensor that measures their blood sugar all the time in 3 periods for a total of 13 weeks (about 3 months) during the study. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

NCT ID: NCT04762628 Completed - Covid19 Clinical Trials

Trial Efficacy of Saisei Pharma Dietary Supplements MAF Capsules, 148 mg and M Capsules, 148 mg in Hospitalized COVID-19 Patients

SaiseiCovUKR
Start date: October 27, 2020
Phase: N/A
Study type: Interventional

The SaiseiCovUKR clinical study is a multicentric, randomized trial study targeting patients hospitalized with COVID-19 who do not require mechanical ventilation. This study aims to provide preliminary data on the activity and safety of MAF capsules and M capsules in the target population after 14 days of dosing. MAF capsules and M capsules are dietary supplements targeting the gut's mucosal immunity to control local and systemic inflammation, limiting epithelial damage and preventing the accumulation of pathological macrophage populations at sites of SARS-CoV-2 infection.

NCT ID: NCT04757376 Completed - Clinical trials for Postmenopausal Women With Osteoporosis

A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis

Start date: June 17, 2021
Phase: Phase 3
Study type: Interventional

This study is a Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis

NCT ID: NCT04738123 Completed - Schizophrenia Clinical Trials

A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-3)

Start date: April 6, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multicenter inpatient study to examine the efficacy and safety of KarXT in adult subjects who are acutely psychotic with a Diagnostic and Statistical Manual Fifth Edition (DSM-5) diagnosis of schizophrenia. The primary objective of the study is to assess the efficacy of KarXT (a fixed combination of xanomeline 125 mg and trospium chloride 30 mg twice daily [BID]) versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate improvement in disease severity and symptoms, safety and tolerability, and pharmacokinetics in adult inpatients with a DSM-5 diagnosis of schizophrenia.

NCT ID: NCT04737187 Completed - Clinical trials for Refractory Metastatic Colorectal Cancer

Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients

SUNLIGHT
Start date: November 25, 2020
Phase: Phase 3
Study type: Interventional

This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.