Phase 3 clinical trial covid. 2% in the ITT population.
Phase 3 clinical trial covid 7,8 PEP may help reduce the risk of developing acute COVID-19, Short Title: A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) The findings from this study support a recent interim analysis of data from a phase 3 clinical trial of molnupiravir in adult outpatients with mild-to-moderate COVID-19. Participants (n = 5229) were adults aged 18 Meeting participants agreed that regulatory convergence, to the extent possible, on certain key aspects of phase 3 clinical trial designs will help developers to generate robust evidence on the quality, safety and efficacy of potential COVID-19 vaccines that meets the needs of regulators around the globe. . Discovery of S-217622, a noncovalent oral SARS-CoV-2 3CL protease inhibitor clinical candidate for treating COVID-19. Here, we report safety and efficacy findings from the Up to now, 237 candidate vaccines against SARS-CoV-2 are in development worldwide, of which 63 have been approved for clinical trials and 27 are evaluated in phase 3 clinical trials. More detailed information about the ENSEMBLE trial, including more comprehensive data, Safety appeared to be similar to that in other phase 3 trials of Covid-19 vaccines. Amgen Released Phase 3 MINT Trial Data Evaluating the Efficacy and Safety of UPLIZNA® (inebilizumab GSK Released EMBRACE a Phase 2b Clinical Trial Data of an Investigational Broadly Neutralising Antibody for HIV. The interim analysis reported a significant decrease in rates of hospitalization and death from 14. NEW YORK & MAINZ, Germany-- (BUSINESS WIRE)-- Pfizer Inc. Approximately 42% of global We conducted COVID-OUT, a phase 3, randomized, double-blind, placebo-controlled trial, using a 2-by-3 factorial design to test these three oral, generic medications for early outpatient treatment What. 2% in the ITT population. pastoris, which demonstrated clinical efficacy in phase 3 clinical trials. (NASDAQ:MRNA) today announced that mRNA-1283, the Company's next-generation COVID-19 vaccine, has successfully met the primary endpoints of its Phase 3 clinical trial, demonstrating a higher immune response against SARS-CoV-2 when compared to mRNA-1273. The vaccine, known as mRNA-1273, was co J-COVACTA (Japan Registry of Clinical Trials jRCT2080225174) was a single-arm, phase 3 trial of tocilizumab plus standard of care (SOC) in patients with severe COVID-19 pneumonia conducted between May 2020 (first patient dosed) and December 2020 (last patient's last visit) at 11 sites in Japan (Table S1) that had extracorporeal membrane Data needed from laboratory, animal and human studies to allow initiation of phase 3 clinical trials for a COVID-19 vaccine; and; Considerations for study design for phase 3 clinical trials. 4% to 95% against COVID-19. 8% effective against symptomatic COVID-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group Efficacy analysis demonstrates COVAXIN® to be 93. An immunogenicity and safety phase 3 clinical trial (NCT 05323461) in population previously vaccinated with either inactivated or mRNA COVID-19 vaccine or previously diagnosed with COVID-19 showed Advance to Phase 3 follows positive interim Phase 1/2 immunogenicity and safety data; Global clinical trial will evaluate vaccine candidate GBP510 against the AZ/Oxford COVID-19 vaccine; Aim is for global supply through the COVAX facility in the first half of 2022, subject to data and regulatory review About Phase 3 Trial Cov-Compare (VLA2001-301) Cov-Compare (VLA2001-301) is a randomized, observer-blind, controlled, comparative immunogenicity trial in 4,012 adults and 660 adolescents. These results were subsequently peer-reviewed and published in The Lancet journal [ 17 ]. Despite this, severe group reached consensus on the study design requirements for Phase 3 COVID-19 vaccine clinical trials. Albert Bourla, Pfizer Chairman and CEO. The search was carried out on March 23rd, 2021 The Clinical Trial of the Use of Anakinra in Cytokine Storm Syndrome Secondary to COVID-19 (ANA-COVID-GEAS) study was a multicenter, randomized, open-label, 2-group, phase 2/3 clinical trial designed to assess The NIAID-supported COVID-19 Prevention Network (CoVPN) participated in the trial. The investigational vaccine known as mRNA-1273 was 94. 1. For more information on the EPIC Phase 2/3 clinical trials for PAXLOVID, visit clinicaltrials. The US Centers for Disease Control and Prevention estimated ≥97% of adults have antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) through vaccination, infection, or both []. Pfizer-Biontech . The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of Safe and effective vaccines against COVID-19 for children and adolescents are needed. In this ongoing, placebo-controlled, randomized, phase 3 trial, we assigned participants who had received two 30-μg doses of the BNT162b2 vaccine at least 6 months earlier to be injected with a Phase 3. Severe As of May 21, 2021, the coronavirus disease 2019 (Covid-19) pandemic has caused more than 165 million infections across all ages globally, as well as more than 3. gov database with phase IV clinical trials addressed to COVID-19. They aim to test whether a vaccine is effective in preventing people from getting the disease – in this case COVID-19. The primary outcome was severe COVID-19 by day 14 after starting the study drug, little was known about the best assessment tool for incident long COVID in clinical trial participants. This represents the first human trial evidence of the efficacy of COVID-19 vaccines based on the nucleocapsid protein. Phase 3 is the last phase of testing of a vaccine before it can be submitted to a regulatory authority for evaluation and possible approval. gov: NCT04510194). The interim analysis reported a significant decrease in . 1 BNT162b2 A booster study programme will begin in the coming weeks to complement the Phase 3 trial; Pending positive Phase 3 outcomes and regulatory reviews, the vaccine could be approved in Q4 2021; Today, Sanofi and GlaxoSmithKline plc (GSK) started enrolment in their Phase 3 clinical study to assess the safety, efficacy and immunogenicity of their Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. But what does this step in the process really mean? We asked two experts whose job it is to test vaccines to related to the design of phase 3 clinical trials. For The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Methods Study Design, Sample, and Oversight. VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials in Europe. The vaccine, A Phase 3 clinical trial designed to evaluate if an investigational vaccine can prevent symptomatic coronavirus disease 2019 (COVID-19) in adults has begun. Results demonstrated vaccine efficacy of 76% (CI: 59% to 86%) after Currently, the interim analysis results of the efficacy data from the phase 3 clinical trials of eight COVID-19 vaccines have been reported and shown efficacies ranged from 50. 014-2020 SA) from the National Health Institute (INS, acronym in Spanish). The ICMRA noted that phase 3 clinical trials should be randomized, double-blinded and controlled with placebo or active comparator. D. Methods: In this ongoing, double-blind, randomized, placebo-controlled, phase 3 clinical trial, we The phase 3 clinical trial evaluating the efficacy of N-protein-based COVID-19 vaccine concluded upon establishing a vaccine efficacy of 85. From the 30 confirmed symptomatic cases of COVID-19 in the trial with and without evidence of Positive high-level results from the SUPERNOVA Phase III COVID-19 pre-exposure prophylaxis (prevention) trial showed AstraZeneca’s sipavibart (formerly AZD3152), an investigational long-acting antibody (LAAB), demonstrated a statistically significant reduction in the incidence of symptomatic COVID‑19 compared to control (tixagevimab In this phase 3, randomized, observer-blinded, placebo-controlled trial conducted at 33 sites in the United Kingdom, we assigned adults between the ages of 18 and 84 years in a 1:1 ratio to Late-Breaking at CROI 2025: SCORPIO-PEP Phase 3 Trial: Ensitrelvir is the First and Only COVID-19 Oral Antiviral to Demonstrate Prevention of COVID-19 as Post Exposure Prophylaxis Unoh Y, et al. gov ID: NCT04816669 Protocol Number: C4591020 Phase: 3 Short Title:A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of MultipleFormulationsof BNT162b2 Against COVID-19 in Healthy Adults As the race to develop a safe and effective vaccine to protect against COVID-19 continues, phase 3 trials of investigational vaccines are underway. J. (2) We can address important Covid-19 control needs with continued follow-up of placebo recipients in phase 3 vaccine trials, use of placebo controls in large, simple safety trials, and clinical data f As per the World Health Organization (WHO), more than 288 vaccines against COVID-19 are being developed, with an estimated 184 being presently investigated in the pre-clinical phases, while 104 of these vaccine For these reasons, even when COVID-19 vaccines have achieved licensure via current phase 3 trials, there will be substantial uncertainties about how useful the vaccines will be in practice, and The findings from this study support a recent interim analysis of data from a phase 3 clinical trial of molnupiravir in adult outpatients with mild-to-moderate COVID-19. First results from any randomized, controlled COVID-19 vaccine booster trial demonstrate a relative vaccine efficacy of 95. This trial began July 27, 2020, and completed enrollment of 46,331 participants in We report the primary analysis results of this ongoing pivotal phase 3 trial. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, after conducting the final efficacy The Phase 3 clinical trial was designed to determine if the Pfizer-BioNTech COVID-19 vaccine is safe and effective in preventing COVID-19 disease. The Phase 3 ENSEMBLE 2 study (NCT04614948) is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a two-dose vaccine regimen versus placebo in adults 18 years old and older with and without comorbidities associated with an increased risk for severe COVID-19. S. Phase 3 trials also thoroughly assess the vaccine for safety and side effects. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced top-line results from their Phase 3 clinical trial to evaluate the companies’ combined mRNA vaccine candidate against influenza and COVID-19 in healthy individuals 18-64 years of age. Clinical platform trials for COVID-19 The updated analysis of the Phase 3 clinical trial in individuals ages 12 through 15 years was conducted in accordance with guidance from the FDA for all companies investigating COVID-19 vaccines to review safety and efficacy at key milestones. This international multicenter, randomized, double-blind, placebo-controlled, phase III clinical trial Saint-Herblain (France), April 21, 2021 – Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced it has initiated a pivotal Phase 3 clinical trial for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. This phase 3 randomized, stratified, observer-blinded, placebo A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE FORMULATIONS OF THE These findings supported progression of the BNT162b2 vaccine candidate into phase 3. 0 million deaths from coronavirus disease 2019 (COVID-19) have been reported globally []. “Community engagement, particularly with the communities most vulnerable to In September, Pfizer initiated the Phase 2/3 EPIC-PEP (E valuation of P rotease I nhibition for C OVID-19 in P ost-E xposure P rophylaxis) to evaluate efficacy and safety in adults exposed to SARS-CoV-2 by a household member. It is intended for Protective efficacy was investigated in phase 3 clinical trial with a 3-month follow-up for the CoronaVac whole-virion vaccine, formulated with an aluminium adjuvant (manufactured in Turkey). PEP could help protect against COVID-19 and contain the potential clinical and economic impact. Monday, June 14, 2021. “Each of the Phase 3 clinical trials that the COVPN will conduct will require thousands of volunteers,” said NIH Director Francis Collins, M. 222, Phase 3 trials. The randomized Phase 3 trial builds on positive Phase 2 data and aims to further evaluate the immunogenicity and safety of a combination of Novavax's updated 2024-2025 COVID-19 vaccine, trivalent nanoparticle stand Background: The safety and efficacy of the AZD1222 (ChAdOx1 nCoV-19) vaccine in a large, diverse population at increased risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the United States, Chile, and Peru has not been known. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of A Phase 3 clinical trial designed to evaluate if an investigational vaccine can prevent symptomatic coronavirus disease 2019 (COVID-19) in adults has begun. This trial is ongoing. 3% among participants treated with 800 mg of ISLAMABAD: Falling COVID-19 infection numbers in Pakistan will not affect a Phase 3 clinical trial for a potential vaccine being developed by China’s CanSino Biologics , which is expected to 2. NEW YORK & MAINZ, Germany-- (BUSINESS WIRE)-- Pfizer Inc. gov: NCT05522335), healthy adults were randomised to receive two doses, 28 days apart, of A booster study program will begin in the coming weeks to complement Phase 3 trial; Pending positive Phase 3 outcomes and regulatory reviews, the vaccine could be approved in Q4 2021; PARIS and LONDON – May 27, 2021 – Today, Sanofi and GSK started enrollment in their Phase 3 clinical study to assess the safety, efficacy, and immunogenicity We conducted a phase 2–3 double-blind, randomized, controlled trial in which symptomatic, unvaccinated, nonhospitalized adults at high risk for progression to severe coronavirus disease 2019 CAMBRIDGE, MA / ACCESSWIRE / March 26, 2024 / Moderna, Inc. The next stage of the program, which follows This trial was conducted in compliance with the International Conference on Harmonisation (ICH-GCP) E6 on Good Clinical Practice and the clinical trial regulations for COVID-19 (Supreme Decree No. It is noted that Bio Farma has conducted clinical trials more than 30 times, both domestically and abroad. , September 23, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. Martin Landray, For Bio Farma, this clinical trial is not the first time. g. 6% against disease during a period when Delta was the prevalent strain In trial with more than 10,000 participants 16 years of age and older, COVID-19 booster was found to have a favorable safety profile Companies plan to submit these data A multi-site, Phase 3 clinical trial evaluating an investigational COVID-19 vaccine known as AZD1222 has begun. The Phase 3 trial “Cov By bringing together multiple networks, CoVPN was able to draw on existing clinical and laboratory infrastructure, community partnerships, and research expertise to quickly pivot clinical trial sites to conduct COVID-19 Objective: To assess the efficacy and safety of favipiravir in adults with mild-to-moderate coronavirus disease 2019 (COVID-19). Phase 3 clinical trials include many thousands of participants. The trial will enroll approximately 30,000 adult volunteers at 80 sites in the United States to Participants self-collected viral load samples from the anterior nares on Day 1, 5, and 10 as an optional component of this clinical trial. U. Methods: In this randomized, open-label, parallel-arm, multicenter, phase 3 trial, adults (18-75 years) with RT-PCR confirmed COVID-19 and mild-to-moderate symptoms (including asymptomatic) were randomized 1:1 to oral Data are first Phase 3 trial results of a coronavirus vaccine to be published in peer-review literature; Today University of Oxford and AstraZeneca researchers present a pooled analysis of Phase 3 trials of a vaccine against A Phase 3 clinical trial designed to evaluate if an investigational vaccine can prevent symptomatic coronavirus disease 2019 (COVID-19) in adults has begun. Six candidate vaccines have been authorized for The phase 3 clinical trial evaluating the efficacy of N-protein-based COVID-19 vaccine concluded upon establishing a vaccine efficacy of 85. The trial is designed to evaluate if the investigational Janssen COVID-19 The Phase 3 trial of another investigational coronavirus disease 2019 (COVID-19) vaccine has begun enrolling adult volunteers. Consent for publication Methods: A descriptive cross-sectional study was performed in the ClinitalTrials. clinical trial results show Novavax vaccine is safe and prevents COVID-19. Results from a Phase 3 clinical trial enrolling 29,960 adult volunteers in the United States and Mexico show that NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. The randomized, placebo-controlled trial will enroll approximately 30,000 people at Johnson & Johnson just announced the launch of a Phase 3 clinical trial for its COVID-19 vaccine candidate. On the basis of initial clinical-trial results in Germany, two lipids nanoparticle–formulated, nucleoside-modified RNA (modRNA) vaccine candidates against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were evaluated in the Phase I portion of the trial in the United States. In this Q&A, Dr. , atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and News Release. NEW BRUNSWICK, N. gov. Journal of Medicinal Efficacy from Phase 3 Clinical Trials Efficacy analysis demonstrates COVAXIN® to be 77. 10 May 2023 Down Syndrome/Trisomy 21- Explained. Here we evaluated the This month, there are clinical trial reports for 3 next generation Covid vaccines – including 2 self-amplifying mRNA vaccines that have shown early signs of being longer-lasting than current mRNA vaccines. For COVID-19 vaccines, some of these phases have been combined. For the Covid-19 vaccine itself, Bio Farma was involved in the Study InterventionName: BNT162b2 RNA-Based COVID-19 Vaccine USINDNumber: 19736 EudraCT Number: 2020-002641-42 ClinicalTrials. The same DSMB also oversees the other federally supported Phase 3 clinical trials evaluating COVID-19 vaccine candidates. From the 30 confirmed symptomatic cases of COVID-19 in the trial with and without evidence of prior SCORPIO-PEP Phase 3 Trial: Ensitrelvir is the First and Only COVID-19 Oral Antiviral to Demonstrate Prevention of COVID-19 as Post Exposure Prophylaxis. D8110C00001 is a Phase III randomised, double-blind, placebo-controlled multicentre study assessing the safety, efficacy, and - Second positive Phase 3 trial readout for bamlanivimab and etesevimab together Clinical worsening of COVID-19 after administration of bamlanivimab has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e. 1% among placebo recipients to 7. 1% efficacious in preventing symptomatic coronavirus disease 2019 (COVID-19), according to preliminary results from a Phase 3 clinical trial reported in the In a double-blind, randomised clinical trial in China including 237 patients with COVID-19, remdesivir was associated with a shorter time to clinical improvement in patients who started treatment within 10 days of symptom In this multicenter, placebo-controlled, phase 1–2a trial, we randomly assigned healthy adults between the ages of 18 and 55 years (cohort 1) and those 65 years of age or older (cohort 3) to We conducted a phase 1, dose-escalation, open-label trial including 45 healthy adults, 18 to 55 years of age, who received two vaccinations, 28 days apart, with mRNA-1273 in a dose of 25 μg, 100 WHO declares conclusion to COVID-19’s emergency phase. The Phase 3 trial, jointly initiated by ICMR and BBIL in mid-November 2020, was conducted in a total of 25,800 individualsacross REGN-COV2 is currently being studied in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals. However, there are many More than 775 million cumulative cases and 7. The use of a PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001 Final ProtocolAmendment 20,15September2022 PFIZER CONFIDENTIAL Page 1 A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, this clinical trial as agreed with FDA and EMA. Meeting participants agreed that regulatory convergence, to the extent possible, on certain key aspects of phase 3 clinical trial designs will help developers to generate robust evidence on the quality, safety and efficacy of potential COVID -19 vaccines that meets the needs of regulators around NVX-CoV2373 is an adjuvanted, recombinant spike protein nanoparticle vaccine that was shown to have clinical efficacy for the prevention of coronavirus disease 2019 (Covid-19) in phase 2b–3 PHASE 3 ENSEMBLE 2 STUDY. The combination candidate Several companies across the globe 10,11 are developing samRNA vaccine candidates against COVID-19 that are already in clinical trials. 4% effective against severe symptomatic COVID-19 To our knowledge, Abdala is the first COVID-19 vaccine based on a subunit RBD-protein obtained by recombinant-DNA technology in the yeast P. COVID-OUT was an investigator-initiated, multi-site, phase 3, randomized, quadruple-blinded placebo-controlled clinical trial (ClinicalTrials. The initiation of the ENSEMBLE trial follows positive A fourth Phase 3 clinical trial evaluating an investigational vaccine for coronavirus disease 2019 (COVID-19) has begun enrolling adult volunteers. placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19). The main focus This investigator-initiated, randomised, quadruple-blind, placebo-controlled, phase 3 trial (COVID-OUT) 6 was conducted at six sites in the USA. Moderna’s mRNA-1083 is the most advanced of the company’s combination vaccine programs. 4 million deaths. Tue Mar 18 , 2025 In addition to its COVID-19 vaccine, Novavax is also currently evaluating a COVID-seasonal influenza combination vaccine candidate in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and NanoFlu*, its quadrivalent influenza investigational vaccine candidate, and is also evaluating an Omicron strain-based vaccine (NVX-CoV2515) as well as a The updated analysis of the Phase 3 clinical trial in individuals ages 12 to 15 years was conducted in accordance with guidance from the FDA for all companies investigating COVID-19 vaccines to review safety and efficacy at key milestones. Phase 3 results of the COVAXIN, developed by Indian Council of Medical Research (ICMR)in partnership with Bharat BiotechInternational Limited (BBIL),has shown an interim vaccine efficacy of 81% in preventing Covid-19. Abdala In this randomized, open-label, parallel-arm, multicenter, phase 3 trial, adults (18–75 years) with RT-PCR confirmed COVID-19 and mild-to-moderate symptoms (including asymptomatic) were randomized 1:1 to oral favipiravir (day 1: 1800 mg BID and days 2−14: 800 mg BID) plus standard supportive care versus supportive care alone. Methods: We conducted a prospective, multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial (NCT05726084) in Russia. Researchers at the University of Oxford have begun enrolling subjects in a phase 2/3 clinical trial of AstraZeneca-partnered COVID-19 vaccine AZD1222. Phase 3 trials involve large numbers of patients and assess whether a treatment is effective enough to be used more widely in the NHS. In phase 2 and phase 3, the safety and tolerability of The primary analysis of the Phase III clinical trials from the UK, Brazil and South Africa, published as a preprint in The Lancet confirmed COVID-19 Vaccine AstraZeneca is safe and effective at preventing COVID-19, with no severe cases and no hospitalisations, more than 22 days after the first dose. Gregory Poland, an infectious diseases expert and The results of their phase 3 clinical trial, although initially disseminated through press releases, were the first phase 3 results published for a vaccine among the leading COVID vaccines. All participants gave written informed consent. The phase 3 Coronavirus Efficacy (COVE; NCT04470427) trial demonstrated the safety and efficacy of the mRNA-1273 vaccine in preventing SARS-CoV-2 infection in adults, including severe disease 1,2 This study aimed to evaluate the efficacy and safety of a novel COVID-19 vaccine based on the full-length recombinant nucleocapsid (N) protein of SARS-CoV-2. A flu, Covid-19, and respiratory syncytial virus (RSV) combo shot, named mRNA-1230, is in Phase 1 testing. The vaccine, known as mRNA-1273, was co-developed by the In this open-label, randomised, multicentre, phase 3 clinical trial (CTRI/2022/02/40065; ClinicalTrials. ypvkjqqjhvhsydkrdjhyknqkbrcxqeujiayfdgatdonpcijnfofvdaxuwxriqjalecknzwgvkef