Active clinical trials for "COVID-19"

This phase 2 study is to assess the safety and tolerability of APX-115 active doses compared to placebo following multiple oral dosing in hospitalized patients with confirmed, mild to moderate, symptomatic COVID-19. It is anticipated that approximately 80 patients will be randomized into the study in a 1:1 ratio to 100 mg APX-115 or placebo arm.

Severe ill Patients will be enrolled in the study (n=310) after duly filled consent forms. Recipients will be divided into 2 group, each group contain 155 patients to compare Safety and efficacy of patients in Clinical Trial phase II/III. One Group will receive 0.15g/kg single dose of anti COVID 19 intravenously immunoglobulin (C-IVIG) develop from convalescent plasma of recovered patients from COVID 19, along with Standard of care. The Comparator group will only receive standard of Care

Objective of the study is to assess the safety and efficacy of CO2 removal by the multiECCO2R (CO2 Removal System) on the multiFiltrate/multiFiltrate Pro in veno-venous extracorporeal circulation during continuous renal replacement therapy (CRRT) in patients presenting with hypercapnia due to acute lung failure and acute kidney injury.

Safety and efficacy of ADR-001 are evaluated in Patients with Severe Pneumonia caused by SARS-CoV-2 infection.

International observational studies confirm the high incidence of post-infectious residual syndrome after infection with severe acute respiratory syndrome corona virus 2 (SARS-COV2), which can occur in 10-15% of all infected persons, regardless of the severity of the acute infection. Post corona virus disease 19 (postCOVID-19) patients suffer mostly from symptoms such as fatigue, muscle pain, problems to focus, depression and sleep disturbances. So far, there are no results of interventional studies for the treatment of chronic fatigue post COVID-19, but there are indicators that post COVID-19 syndrome is a chronic subclinical inflammation, similar to Chronic Fatigue Syndrome / Myalgic Encephalomyelitis CSF/ME, which also often develops from a postviral syndrome. Previously tested and effective strategies for the treatment of chronic fatigue syndrome / myalgic encephalomyelitis (CFS/ME) will be tested in the treatment of chronic fatigue postCOVID-19, in this randomized controlled trial a combination of acupressure and Qigong. The aim of this project is to evaluate an acupressure treatment plus a Qigong exercise series specifically tailored for chronic fatigue postCOVID-19 , used daily by the patients themselves and regularly supervised, in comparison to the advice literature on the treatment of PostCOVID-19 syndrome alone.

This study is a randomized, double-blind, placebo-controlled clinical trial to investigate the safety and efficacy of BEJO Red Ginger in hospitalized adult (18 - 50 years old) COVID-19 patients with mild clinical manifestations. Subjects will be screened during hospitalization. One hundred and sixty-eight patients with confirmed SARS-CoV-2 infection and meeting all criteria, will be recruited to receive either BEJO Red Ginger or placebo in addition to standard of care (SOC) in a 1:1 ratio. Patients with a diagnosis of COVID-19 and, due to mild symptoms, hospitalized, will be randomized to take a sachet of syrups containing 15 ml of BEJO Red Ginger, 3 times a day: 1 sachet after breakfast, 1 sachet after lunch, and 1 sachet after dinner, as add-on to the SOC, with 2 hours of incubation of SOC. The treatment will last for 14 days or until patients to be declared as cured. The treated patients will be compared with an equal group treated with placebo and SOC. Recovery time, symptoms, and objective (inflammatory) parameters (see detailed description) will be analyzed as outcomes. The goal of this study is to evaluate the role of BEJO Red Ginger in preventing progression of COVID-19 and accelerating healing process in patients.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the coronavirus associated with COVID-19 (Coronavirus Disease 2019), invading the respiratory tract, and leading to symptoms from dysgeusia, anosmia, fever, headache and cough to dyspnea and severe respiratory failure and even death. In order to obtain its pathogenic activity, the SARS-CoV-2 relies on its spike protein to enter the cells of the infected patient. This infection leads to a variable severity spectrum, with the majority of forms of mild entity (upper respiratory tract infection or lower respiratory tract without respiratory failure or insufficiency of other organs) despite the presence of a considerable share of severe infections in need hospitalization in sub-intensive or intensive area (up to 6% of cases) with invasive and non-invasive respiratory support. Approximately 14% of patients have experienced severe disease and 5% have been critically ill. In the context of global pandemic, Fab'entech is currently developing polyclonal F(ab')2 equine fragments directed against the SARS-CoV-2 spike protein. Indeed, as virus entry within the cell requires this protein, Fab'entech proposes a way to block this event, neutralizing viral replication, and therefore inhibiting pathogenic activity of the virus. The objective of this two-stage randomized, placebo-controlled, double blind, phase 2a study is to characterize the safety and pharmacokinetics of FBR-002 in patients hospitalized with COVID-19 in need of supplemental oxygen and at risk of severe outcome

Primary objective: - To evaluate the efficacy of oral reparixin versus standard care alone in limiting disease progression in adult patients hospitalised for infectious pneumonia acquired in the community (CAP), including COVID-19. Secondary objectives: - To determine the effect of reparixin on several disease severity/progression measures including recovery, ventilatory free days and mortality. Safety objectives: - To evaluate the safety of oral reparixin versus placebo in the specific clinical setting.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections are rapidly spreading worldwide and continue to be a global public health crisis. The use of repurposed drugs with the potential to inhibit SARS-CoV-2 could be a vital alternative approach when the novel therapeutic has not yet available. The guidelines for emergency treatment of COVID-19 vary across different countries and largely rely on the off-label prescription of repurposed drugs. As a result, clinical studies to generate robust efficacy data for these repurposed drugs are warranted to effectively fight against the ongoing COVID-19 pandemic. The broad spectrum antiparasitic drug ivermectin has previously been shown to exhibit broad antiviral activities against many RNA and DNA viruses. It has a reliable safety profile with comprehensive data for decades especially in mass drug administration programs for river blindness prophylaxis in several countries in Africa. Owing to its strong inhibitory activity against the replication of SARS-CoV-2 in vitro and its putative role in reducing cytokine storm, the drug has been repurposed to treat COVID-19 patients and has shown promising results in several clinical studies. Ivermectin has thus gained a considerable attention as a potential treatment for COVID-19. However, the National Institute of Health (NIH) and World Health Organization (WHO) currently state that studies on using ivermectin to treat COVID-19 patients remain inconclusive due to insufficient data. Therefore, a large well designed randomized, double blinded, placebo-controlled trial to assess the efficacy of ivermectin is urgently needed. Another important treatment option for COVID-19 is favipiravir, an antiviral drug for influenza treatment. Although the drug has not been approved for a COVID-19 treatment by the US-FDA, it has been included in Guidelines on clinical practice, diagnosis, treatment, and prevention of healthcare-associated infection for COVID-19 in Thailand. Favipiravir, a known inhibitor of RNA-dependent RNA polymerase, was shown to have an in vitro activity against SARS-CoV-2. The meta-analysis showed a significant improvement in clinical outcome at day 14 along with chest imaging in the favipiravir group compared to standard care. However, there are no significant differences in terms of clinical deterioration rates, viral clearance, oxygen support requirement and side effect profiles. There are still ongoing clinical trials assessing the effectiveness of favipiravir in the treatment of COVID-19. Antivirals can be generally divided into direct-acting antivirals (DAA) and host-targeting drugs. For example, the widely used drug remdesivir repurposed to treat COVID-19 is a DAA, and chloroquine is considered a host-targeting drug. Because these repurposed drugs were not specifically designed and developed for COVID-19, they are likely to be less efficacious, and partner drugs need to be further explored. Finding a right combination for DAA is a common practice for developing virus treatment regimens. Relying on different modes of action and absence of unfavorable drug interaction, the combinations are usually additive or synergistic. It is important to note that our in vitro data demonstrated the synergistic profile for the combination of favipiravir and ivermectin against SARS-CoV-2. It resulted in 4-fold reduction in the half maximal inhibitory concentration (IC50) as compared to individual drugs, from 1.2 µM to 0.3 µM with a peak Loewe synergy score of over 33.2 and a mean score of 18.8 (noted that Loewe synergy score > 10 indicates synergistic effect). In response to this COVID-19 pandemic crisis, especially in a resource limited setting like Thailand, clinical studies to evaluate affordable and implementable interventions are a priority and are urgently needed. Ivermectin, a cheap and safe drug, has been widely used in humans for decades, and it has also demonstrated an inhibitory effect against SARS-CoV-2 in vitro. Here, we aim to conduct a multi-center, double-blind, randomized controlled trial in Thailand to reveal the effectiveness of ivermectin as a combination therapy with favipiravir (standard treatment) for COVID-19. The results of this study will provide much needed information for pursuing larger efficacy clinical trials to confirm whether the combination could be effectively used to treat COVID-19. Also, they could provide information on the rate of viral clearance, the primary endpoint of this study, which was proposed to be a predictive surrogate of clinical benefits and used as a proper endpoint in the phase II trials for candidate drug screening for COVID-19.

COVID-19 associated mortality remains high despite the advances in therapeutics such as dexamethasone. The severity of COVID-19 results from direct viral cytotoxicity, and the inflammatory response, which is associated with a hypercoagulable state, contribute to lethal hypoxemic pneumonia. During the SARS-CoV-2 replication phase, infected cells secrete chemokines and die by activating the immune system locally. A local inflammatory loop induces tissue destruction, which activates the immune system's circulating cells, leading to another amplifying loop called the cytokine storm. In these phenomena, the integrity of the interferon pathway plays a significant role. Specific impairment of the interferon pathway has been identified in a subset of patients and is associated with high Covid-19 severity. This subset of patients presents preexisting autoimmune disease mediated by autoantibodies directed against IFN. It represents 10.2% (101/987) of patients admitted in ICU with COVID-19 pneumonia, and the observed mortality in this subgroup is 40%. The investigators hypothesized that plasma exchanges (PE) would eliminate these autoantibodies while acting on other mechanisms of the pathogenesis of severe COVID-19, such as cytokine storm or hypercoagulability(7). The EPIC trial aims to demonstrate the efficacy of plasma exchange in the subpopulation of patients with anti-interferon autoantibodies and severe COVID-19 hospitalized in intensive care and on oxygen therapy, high flow or not, receiving non-ventilation or invasive ventilation, on D28 survival.