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CLINICAL TRIALS PROFILE FOR VEKLURY

All Clinical Trials for VEKLURY

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04784559 ↗	Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection	Recruiting	PharmaMar	Phase 3	2021-06-04	Treatment of patients hospitalised for management of moderate COVID-19 infection
NCT04832880 ↗	Factorial Randomized Trial of Rendesivir and Baricitinib Plus Dexamethasone for COVID-19 (the AMMURAVID Trial)	Not yet recruiting	ASST Fatebenefratelli Sacco	Phase 3	2021-04-06	Background: In the current worldwide medical emergency, a rapid identification of effective therapeutic strategy is crucial. So far, therapy with dexamethasone, remdesivir and baricitinib have been associated with evidence of impact on the clinical impact on COVID-19, but the effect of baricitinib and remdesivir in combination with dexamethasone. The AAMMURAVID trial is endorced and supported by the Italian Regulatory agency (AIFA-Agenzia Italiana del Farmaco)
NCT04853901 ↗	Remdesivir Efficacy In Management Of COVID-19 Patients	Completed	Ain Shams University	Phase 3	2020-07-27	The study is open label randomized interventional phase 3 clinical trial. Patients with confirmed Covid-19 cases who was hospitalized in Two university isolation hospitals (Ain Shams University and Assiut University ) assigned hospitals for isolation.
NCT04871633 ↗	Effectiveness of Remedesvir in COVID-19 Patients Presenting at Mayo Hospital Lahore	Completed	King Edward Medical University	N/A	2020-08-01	Currently, several drugs including Remdesivir, hydroxychloroquine, chloroquine, ritonavir+lopinavir, Tocilizumab, Arbidol and interferon are under randomised controlled trials (RCTs) for efficacy and/or safety evaluations in patients with COVID-19 in different countries. Remdesivir (GS-5734) is among these investigational drugs and some studies reported promising results. Remdesivir is a nucleotide analogue intravenous pro-drug developed by Gilead Sciences, an American biopharmaceutical company, for treatment of Ebola virus during the 2014 Ebola outbreak in Western Africa. Remdesivir shows broad-spectrum antiviral activity against many RNA viruses including SARS-CoV-2 through blocking RNA polymerase thereby terminating RNA transcription. Remdesivir was among the first treatments used in China as the outbreak emerges and it has been reported as potential treatment options for COVID-19 in the USA, China and Italy.
NCT05502081 ↗	Clinical Study to Compare Efficacy and Safety of Casirivimab and Imdevimab Combination, Remdesivir and Favipravir in Hospitalized COVID-19 Patients	Completed	Mansoura University Hospital	Phase 4	2021-11-01	Introduction: Corona Virus induced disease - 2019 (COVID-19) pandemic stimulates research works to find a solution to this crisis from starting 2020 year up to now. With ending of 2021 year, various advances in pharmacotherapy against COVID-19 have emerged. Regarding antiviral therapy, Casirivimab and imdevimab antibody combination is a type of new immunotherapy against COVID-19. Standard antiviral therapy against COVID-19 includes Remdesivir and Favipravir. Aim of Study: 1. To compare the efficacy of antibodies cocktail (casirivimab and imdevimab), Remdesivir and Favipravir in reducing 28-day mortality in hospitalized patients with moderate, severe or critical COVID19 2. To compare safety of antibodies cocktail (casirivimab and imdevimab), Remdesivir and Favipravir by monitoring hypersensitivity and infusion related reactions or other significant adverse effects Patients and Population: 265 COVID-19 Polymerase Chain Reaction (PCR) confirmed patients with indication for antiviral therapy is included in this study and will be divided into 3 groups (1:2:2): 1. Group A: REGN3048-3051(Antibodies cocktail (casirivimab and imdevimab)) 2. group B: Remdesivir 3. group C: Favipravir Methods: Study design is single blind non-Randomized Controlled Trial (non-RCT). The drugs of the study are owned by Mansoura University Hospital (MUH), and prescribed by chest diseases lectures of faculty of medicine-Mansoura University. The duration of study is about 6 months after ethical approval.
NCT05911906 ↗	An Open-label, Clinical Feasibility Study of the Efficacy of Remdesivir for Long-COVID.	Not yet recruiting	Peninsula Clinical Trials Unit	Phase 4	2024-06-01	Following an infection with Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV2), one in ten people will experience persisting symptoms, or develop symptoms which can last for months and even years. These symptoms affect people in different ways and have been demonstrated to broadly impact physical, mental, and cognitive health. This is called Long COVID. Currently, there are no treatments available to address the issues that patients experience but anti-viral medications have been suggested as being potentially effective. This study will recruit patients that have confirmed long COVID and participants will undertake a series of tests to determine their symptoms and the impact that their condition has had on their bodily systems. The total duration of each participant's involvement is approximately 8 weeks, and this will involve 13 visits (15 visits if taking part in Exeter) at the closest study location (Derby or Exeter). Initial assessments are conducted over three separate visits and then all participants will be scheduled to receive five consecutive days of a medication that has been identified as having the potential to reduce the impact of Long COVID. Following a period of 28 days, participants will be invited to repeat the same tests that were conducted before receiving the medication so that it can be determined how well the drug has worked. In this study we are specifically collecting information to understand how feasible this medication could be to help patients improve their condition and this will help us to determine how likely this drug is able to be used within the wider Long COVID community. The medication that will be used within this study is an existing anti-viral medication (Remdesivir). If we find patients are able to tolerate the treatment and the research tasks we will use this information to conduct a larger trial to determine how well this drug can be used to reduce the impact of Long COVID in a greater number of patients.
NCT05911906 ↗	An Open-label, Clinical Feasibility Study of the Efficacy of Remdesivir for Long-COVID.	Not yet recruiting	University Hospitals of Derby and Burton NHS Foundation Trust	Phase 4	2024-06-01	Following an infection with Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV2), one in ten people will experience persisting symptoms, or develop symptoms which can last for months and even years. These symptoms affect people in different ways and have been demonstrated to broadly impact physical, mental, and cognitive health. This is called Long COVID. Currently, there are no treatments available to address the issues that patients experience but anti-viral medications have been suggested as being potentially effective. This study will recruit patients that have confirmed long COVID and participants will undertake a series of tests to determine their symptoms and the impact that their condition has had on their bodily systems. The total duration of each participant's involvement is approximately 8 weeks, and this will involve 13 visits (15 visits if taking part in Exeter) at the closest study location (Derby or Exeter). Initial assessments are conducted over three separate visits and then all participants will be scheduled to receive five consecutive days of a medication that has been identified as having the potential to reduce the impact of Long COVID. Following a period of 28 days, participants will be invited to repeat the same tests that were conducted before receiving the medication so that it can be determined how well the drug has worked. In this study we are specifically collecting information to understand how feasible this medication could be to help patients improve their condition and this will help us to determine how likely this drug is able to be used within the wider Long COVID community. The medication that will be used within this study is an existing anti-viral medication (Remdesivir). If we find patients are able to tolerate the treatment and the research tasks we will use this information to conduct a larger trial to determine how well this drug can be used to reduce the impact of Long COVID in a greater number of patients.

Clinical Trial Conditions for VEKLURY

Condition Name

Condition Name for VEKLURY
Intervention	Trials
COVID-19	3
Covid19	2
COVID-19 Infection	1
SARS-CoV-2 Infection	1

Condition MeSH

Condition MeSH for VEKLURY
Intervention	Trials
COVID-19	6
Post-Acute COVID-19 Syndrome	1
Infections	1
Infection	1

Clinical Trial Locations for VEKLURY

Trials by Country

Trials by Country for VEKLURY
Location	Trials
Spain	8
Brazil	7
Mexico	6
Argentina	4
Colombia	4

Clinical Trial Progress for VEKLURY

Clinical Trial Phase

Clinical Trial Phase for VEKLURY
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
N/A	1

Clinical Trial Status

Clinical Trial Status for VEKLURY
Clinical Trial Phase	Trials
Completed	3
Not yet recruiting	2
Recruiting	1

Clinical Trial Sponsors for VEKLURY

Sponsor Name

Sponsor Name for VEKLURY
Sponsor	Trials
King Edward Medical University	1
Mansoura University Hospital	1
Peninsula Clinical Trials Unit	1

Sponsor Type

Sponsor Type for VEKLURY
Sponsor	Trials
Other	8
Industry	1

VEKLURY Market Analysis and Financial Projection

VEKLURY (Remdesivir): Clinical Trials, Market Analysis, and Projections

Introduction to VEKLURY

VEKLURY, also known as remdesivir, is an antiviral medication developed by Gilead Sciences for the treatment of COVID-19. It has been a crucial component in the global response to the pandemic, particularly for hospitalized patients.

Clinical Trials and Efficacy

Key Clinical Trials

VEKLURY's efficacy has been evaluated in several significant clinical trials:

• ACTT-1 Trial: This trial demonstrated that VEKLURY-treated patients had a shorter time to recovery compared to those receiving a placebo. The median time to recovery was 10 days for the VEKLURY group versus 15 days for the placebo group[3].
• CARAVAN Study: This Phase II/III study in children under 18 years of age showed clinical improvement and recovery in a high proportion of hospitalized patients[1].
• PINETREE Trial: This Phase III study in participants aged 12 years and older (weighing over 40 kg) showed that VEKLURY significantly reduced the risk of hospitalization or death[1].

Efficacy in Vulnerable Populations

Recent studies have further demonstrated VEKLURY's efficacy in vulnerable patient populations:

• Patients with Severe Renal Impairment: A Phase 3 clinical study showed that VEKLURY was generally well tolerated in people with moderate to severe renal impairment[4].
• Immunocompromised Patients: Real-world evidence studies indicated that VEKLURY treatment was associated with a lower risk of death and reduced hospital readmission rates in immunocompromised patients, including those with cancer and other immunosuppressed conditions[4].

Regulatory Approvals and Indications

Extended Indications

VEKLURY has received provisional approval from several regulatory bodies for extended indications:

• Therapeutic Goods Administration (TGA): Approved for use in adults and pediatric patients with pneumonia due to SARS-CoV-2 who require supplemental oxygen, and in adults and pediatric patients at high risk of progressing to severe COVID-19 without needing supplemental oxygen[1].
• US FDA: Approved for similar extended indications[1].
• European Medicines Agency (EMA): Approved for adults at increased risk of progressing to severe COVID-19 without needing supplemental oxygen, with an ongoing evaluation for use in children[1].

Market Analysis

Sales Performance

VEKLURY has had a significant impact on Gilead Sciences' financial performance:

• Resurgence in Sales: After a decline in sales in the early part of 2021, VEKLURY saw a resurgence due to the delta variant, generating over $4.2 billion in sales for 2021, far exceeding initial projections[2].
• Third Quarter 2021: VEKLURY sales reached $1.9 billion, contributing to Gilead's overall revenue of $7.4 billion for the quarter[2].
• Recent Trends: As of the second quarter of 2024, VEKLURY sales decreased by 16% to $214 million, reflecting declining COVID-19 hospitalizations[5].

Market Impact

VEKLURY's market impact is multifaceted:

• Global Availability: Approved in over 50 countries, VEKLURY has been made available to nearly 13 million patients worldwide, including more than 8 million in middle- and low-income countries through Gilead’s voluntary licensing program[4].
• Competitive Landscape: While VEKLURY remains a key treatment for COVID-19, Gilead's overall product sales, excluding VEKLURY, have shown stability, driven by sales of therapies for HIV, oncology, and liver diseases[5].

Projections and Future Outlook

Sales Projections

Given the current trends in COVID-19 hospitalizations, analysts project a decline in VEKLURY sales:

• 2022 and Beyond: Analysts expect VEKLURY sales to decline quickly in 2022 and contribute only $86 million in sales by 2025[2].
• Gilead's Financial Guidance: Despite the decline in VEKLURY sales, Gilead's overall financial guidance remains positive, driven by other product lines such as HIV and oncology therapies[5].

Future Developments

Gilead continues to invest in COVID-19 treatments:

• Obeldesivir (GS-5245): A novel investigational oral compound being developed for the treatment of SARS-CoV-2 infection, showing promising results in Phase 1 studies[4].

Key Takeaways

• VEKLURY's Efficacy: Clinical trials and real-world evidence have consistently shown VEKLURY's effectiveness in reducing recovery time and improving outcomes for COVID-19 patients.
• Regulatory Approvals: Extended indications approved by multiple regulatory bodies highlight VEKLURY's versatility and critical role in treating various patient populations.
• Market Performance: Despite recent declines, VEKLURY has been a significant contributor to Gilead's revenue, especially during periods of high COVID-19 hospitalizations.
• Future Outlook: While VEKLURY sales are projected to decline, Gilead's diversified portfolio and ongoing research in new treatments ensure a strong financial position.

FAQs

What is VEKLURY used for?

VEKLURY (remdesivir) is used for the treatment of COVID-19 in adult and pediatric patients, particularly those requiring supplemental oxygen or at high risk of progressing to severe COVID-19.

How effective is VEKLURY in treating COVID-19?

Clinical trials have shown that VEKLURY reduces the time to recovery and improves clinical outcomes in patients with COVID-19, especially in vulnerable populations such as those with severe renal impairment and immunocompromised patients.

Has VEKLURY received regulatory approvals?

Yes, VEKLURY has received provisional approvals from the TGA, US FDA, and EMA for extended indications, including use in pediatric patients and those at high risk of severe COVID-19.

What is the current market trend for VEKLURY sales?

VEKLURY sales have declined in recent quarters due to decreasing COVID-19 hospitalizations but previously saw a resurgence during the delta variant wave.

What are the future projections for VEKLURY sales?

Analysts project that VEKLURY sales will decline significantly by 2025, contributing only $86 million, as COVID-19 hospitalizations continue to decrease.

Sources

1. Therapeutic Goods Administration (TGA). COVID-19 treatment: Gilead Sciences Pty Ltd, remdesivir (VEKLURY).
2. FiercePharma. Resurgent Veklury delivers Gilead $1.9B in sales and an earnings surprise.
3. FDA. Drug Trials Snapshots: VEKLURY.
4. Biospace. Veklury® (Remdesivir) Efficacy and Safety Profile Further Demonstrated in Vulnerable Patient Populations.
5. Gilead Sciences. Gilead Sciences Announces Second Quarter 2024 Financial Results.