remdesivir inhalation (GS-5734 inhalation) / Gilead - LARVOL DELTA

Pharmacokinetics, safety, and tolerability of inhaled remdesivir in healthy participants. (PubMed, Clin Transl Sci) - "Following single RDV doses, RDV, GS-704277, and GS-441524 plasma PK parameters indicated dose-proportional increases in area under the concentration-time curve (AUC) extrapolated to infinite time, AUC from time zero to last quantifiable concentration, and maximum observed concentration. Single- and multiple-dose inhaled RDV exhibited linear and dose-proportional plasma PK. Administration of RDV via inhalation was generally safe and well tolerated."

Journal • PK/PD data • Cough • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Inhalable dry powder containing remdesivir and disulfiram: Preparation and in vitro characterization. (PubMed, Int J Pharm) - "In a summary, a combinational dry powder formulation containing remdesivir and disulfiram suitable for inhalation was developed by spray-drying technique which showed high cell viability in the respiratory cell line (Calu-3 cells) retaining their anti-SARS-CoV-2 property. In the future, in vivo studies will test the ability of these formulations to inhibit SARS-CoV-2 which is essential for clinical translation."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Integrated continuous manufacturing of inhalable remdesivir nanoagglomerate dry powders: design, optimization and therapeutic potential for respiratory viral infections. (PubMed, Int J Pharm) - "No statistically significant differences were observed in the critical quality attributes of the inhalable nanoagglomerate powders produced from the continuous manufacturing and standalone batch modes. This work demonstrates the feasibility of large-scale continuous manufacturing of inhalable nanoagglomerate dry powder formulations, which pave the way for their clinical translation."

Journal • Infectious Disease

Autopsy Findings of Severe COVID-19 Pneumonia Combined with Pulmonary Aspergillosis, Pneumothorax, and Pulmonary Thromboembolisms. (PubMed, Am J Case Rep) - "Despite oxygen inhalation, remdesivir, dexamethasone (6.6 mg per day), and baricitinib (4 mg per day for 12 days), the disease progressed...Dexamethasone was switched to methylprednisolone (1000 mg per day for 3 days, and then reduced by half every 3 days), and intravenous heparin was initiated...It is not easy to improve these conditions simultaneously because their treatments can induce antagonizing biological actions. To prevent severe COVID-19, it is important to reduce risk factors, such as by vaccination and appropriate blood glucose control."

Journal • Acute Respiratory Distress Syndrome • Cardiovascular • Diabetes • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Pulmonary Embolism • Respiratory Diseases

EARLY VS LATE MORTALITY IN PATIENTS HOSPITALIZED WITH COVID-19 AT A COUNTY HOSPITAL (CHEST 2022) - "Early mortality in patients with COVID-19 is associated with shorter time to symptoms onset and the lower likelihood to have received systemic steroids, systemic anticoagulation, remdesivir and inhaled epoprostenol. CLINICAL IMPLICATIONS: Early recognition and intervention may prevent early mortality in COVID-19 patients. Reference: Sun, Q., Qiu, H., Huang, M. et al. Lower mortality of COVID-19 by early recognition and intervention: experience from Jiangsu Province. Ann."

Clinical • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Critical care • Diabetes • Fibrosis • Gastroenterology • Heart Failure • Hepatology • Human Immunodeficiency Virus • Hypertension • Immunology • Infectious Disease • Liver Cirrhosis • Metabolic Disorders • Novel Coronavirus Disease • Oncology • Respiratory Diseases • CRP

Remdesivir Powders Manufactured by Jet Milling for Potential Pulmonary Treatment of COVID-19. (PubMed, Pharm Dev Technol) - "This work aims to prepare inhalable remdesivir formulations and verify their effectiveness through in vitro evaluations.Formulations containing different ratios of jet-milled inhalable remdesivir (5%, 10%, 20%,40%,70%) with excipients were produced and characterized in terms of the particle size distribution, particle morphology, flowability, water content, crystallinity, the water sorption and desorption capabilities and the aerodynamic performance.Results indicating that drug loading is a vital factor in facilitating the dispersion of remdesivir dry powder, and the ternary excipient plays a negligible role in improving aerosol performance. Besides, the 70% remdesivir with lactose carrier (70%RD-Lac) was physically stable and retain high aerosol performance after conditioned at 40 °C and 75% RH for a month. Therefore, formulation 70% RD-Lac might be recommended as a candidate product for the potential treatment of COVID-19."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Don't Feel Guilty About Not Finding Remdesivir for Your Loved One. It Hardly Works (MSN News) - "Another latest study led by researchers at Johns Hopkins Medicine supports use of Remdesivir for patients on low-flow oxygen or no oxygen. The study's lead author, Dr Brian Garibaldi...the study clarifies in the column under conflict of interest disclosures."

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"Inhaled #remdesivir at 0.54 mg/kg has similar efficacy as 10 mg/kg IV against #SARSCoV2 in non-human primates @ScienceTM Too bad @GileadSciences stopped pursuing this back in July. https://t.co/7C5nrynes9" (@victoriacyanide)

Clinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Inhaled remdesivir reduces viral burden in a nonhuman primate model of SARS-CoV-2 infection. (PubMed, Sci Transl Med) - "[Figure: see text]."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"Inhaled remdesivir reduces viral burden in a nonhuman primate model of SARS-CoV-2 infection https://t.co/2LqZRuk5dc" (@Amir_Ahmed_Toor)

Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Liposomal remdesivir inhalation solution for targeted lung delivery as a novel therapeutic approach for COVID-19. (PubMed, Asian J Pharm Sci) - "Compared to other preparations, the superiority of Rdv-lips was further evidenced by the results of an in vivo safety study, with little possibility of inducing inflammation. In conclusion, Rdv-lips for pulmonary delivery will be a potent formulation to improve the in vivo behavior of remdesivir and exert better therapeutic effects in COVID-19 treatment."

Journal • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

Inhaled remdesivir treatment for COVID-19. (PubMed, Int J Tuberc Lung Dis) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease

Gilead Sciences (GILD) Q2 2021 Earnings Call Transcript (The Motley Fool) - "We've decided not to move forward with an inhaled formulation of remdesivir based on the results of our initial proof-of-concept study, suggesting suboptimal lung deposition. To address patient needs in the evolving pandemic, we are continuing our efforts on advancing multiple novel antivirals....The inhaled nebulized approach didn't give us the results we were hoping for, the consistency we were looking for."

Discontinued • Infectious Disease • Novel Coronavirus Disease

Remdesivir is not lifesaving, says Mayo Clinic disease specialist (The Week) - "The one piece of equipment you should get to keep at home is the oxygen saturation meter. This measures the amount of oxygen in your blood and can be helpful in determining when you need to go to the hospital. If the oxygen percentage as detected by the meter is less than 92 per cent, that is the point at which you need oxygen and medication called dexamethasone or another kind of steroid. Even this can be done at home for many people, but if there is no possibility of arranging for oxygen at home and if hospital beds are available, this would be a good time to get admitted."

Interview • Novel Coronavirus Disease

'Mucor is very scary' - "Dr Priya Sampathkumar...is watching closely, daily, the twists and turns of India's pandemic story with deep anxiety and concern. She is not just watching, but has thrown herself into doing whatever she can, all the way from Rochester Minnesota. She is part of the India COVID SOS Mission, a group of scientists, academics, engineers, doctors, social workers, businesspersons, students tirelessly supporting India's difficult battle against COVID-19 with resources, solutions, information and aid."

Media quote • Novel Coronavirus Disease

The Stages of COVID and home treatments - COVID-19 Relief Series (YouTube) - "Dr. Bindu Anand Balani was the principal investigator in both Moderna's COVID Vaccine Study and the Remdesivir Study at Hackensack University Medical Center which is the part of Hackensack Meridian Health in New Jersey. She will answer your questions on identifying stages of COVID-19 at home, when to get tested, when to seek medical assistance, breathing exercises, prone sleeping, Remdesivir and much more. Join us live for an opportunity to ask your questions."

Video

How hospitals worldwide are trying to find ways to treat ‘sickest of the sick’ COVID-19 patients (Deseret News) - "The 'devastating' syndrome is the primary cause of death in patients with COVID-19, Brown said. The ACTIV-3 Critical Care trial testing the effectiveness of two drugs, Zyesami and the antiviral remdesivir (Veklury), in treating patients hospitalized with life-threatening cases of COVID-19 was announced last week by the federal government."

Media quote • Novel Coronavirus Disease

Basic aspects of COVID-19 for management from primary care (PubMed, Aten Primaria) - "In hospital patients, remdesivir reduces recovery time. Antibiotherapy is limited to cases of high suspicion of bacterial superinfection. Mild-moderate and severe cases after discharge from hospital should be clinically monitored for a minimum period of two weeks."

Clinical • Journal • Fatigue • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study in Participants With Early Stage Coronavirus Disease 2019 (COVID-19) to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation (clinicaltrials.gov) - P1b/2a; N=156; Completed; Sponsor: Gilead Sciences; Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

[VIRTUAL] Update on Remdesivir for the treatment of COVID-19 (ACS-Sp 2021) - "RDV is currently being tested in combinations with a variety of other agents including anti-inflammatory drugs as well as neutralizing antibodies to potentially further enhance the clinical impact in hospitalized settings. In addition, a newly developed inhaled formulation of RDV is undergoing a Phase2 evaluation in out-patient settings with a goal to prevent disease progression and reduce hospitalization following COVID-19 diagnosis."

Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Journey From SARS-CoV-2 to COVID-19 and Beyond: A Comprehensive Insight of Epidemiology, Diagnosis, Pathogenesis, and Overview of the Progress into Its Therapeutic Management. (PubMed, Front Pharmacol) - "Although remdesivir as an antiviral had been approved for use in those above 12 years of age and 40 kg weight group, it has been observed to be ineffective in large-scale SOLIDARITY trials by WHO...Two vaccines were found to be significantly promising in phase III results. It is concluded that till the approval of a specific treatment or development of a vaccine against this deadly disease, the preventive measures should be followed strictly to reduce the spread of the disease."

Clinical • Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Clinical and Therapeutic Approach to Hospitalized COVID-19 Patients: A Pediatric Cohort in Portugal. (PubMed, Acta Med Port) - "A significant proportion of our population presented severe and critical disease, was hospitalized and received treatment according to the most recent data, although most patients had mild disease. COVID-19 treatment in children is a clinical challenge and clinical trials are urgently needed."

Clinical • Journal • Acute Respiratory Distress Syndrome • Cardiovascular • Infectious Disease • Novel Coronavirus Disease • Pediatrics • Pneumonia • Respiratory Diseases • Septic Shock

Study in Participants With Early Stage Coronavirus Disease 2019 (COVID-19) to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation (clinicaltrials.gov) - P1b/2a; N=156; Active, not recruiting; Sponsor: Gilead Sciences; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

IDSA Updates COVID Guidelines for Antibodies, Antivirals, Other Drugs (Medscape) - P2, N=NA; BLAZE-1 (NCT04427501); "'The guideline panel gave a conditional recommendation against the routine use of bamlanivimab,' Adarsh Bhimraj, MD...said."

Media quote • P2 data • Regulatory

New drugs identified as possible tools to fight COVID-19 (National Geographic) - "For now, only two medications are widely agreed upon to be effective against COVID-19. The first is the expensive antiviral drug remdesivir, which shortens hospital stays by disrupting the virus's ability to replicate, but it doesn't seem to reduce the risk of dying from COVID-19. The other, the inexpensive steroid dexamethasone, is the only medication confirmed in clinical trials to reduce the risk of death among severe COVID-19 patients. 'Hands-down, people believe steroids are useful,' Bhimraj says."

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