Pharmacological strategies to prevent SARS-CoV-2 infection and treat the early phases of COVID-19

Scarabel, Lucia; Guardascione, Michela; Bo, Michele Dal; Toffoli, Giuseppe

doi:10.1016/j.ijid.2021.01.035

Cited by 22 publications

(22 citation statements)

References 46 publications

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“…The trial was conducted in two parts (Figure 1). In part 1 (sentinel dosing), 10 adults (18À55 years of age) were randomly assigned to receive two intramuscular (IM) injections of V591 at different dosing levels (1£10 5 [panel A] or 1£10 6 [panel B] of the median tissue culture infectious dose [TCID 50 ]) or placebo on Days 1 and 57 in a 4:1 ratio. A standing internal Data Monitoring Committee reviewed at least 7 days of safety and tolerability data following the first injection for all 10 participants in part 1 before initiating part 2 of the trial.…”

Section: Trial Design and Participantsmentioning

confidence: 99%

“…In part 2, adults aged 18À55 years (part 2A) and >55 years (part 2B) were randomly assigned to receive V591 (either a single dose or two doses) or placebo in a 4:1 ratio at different dosing regimens (panels CÀL), as outlined in Figure 1. All participants in part 2A were assigned to receive 1£10 4 , 1£10 5 , 1£10 6 or 1£10 7 TCID 50 of V591 or placebo and all participants in part 2B were assigned to receive 1£10 5 or 1£10 6 TCID 50 of V591 or placebo. Dose levels were selected based on previous experience with measles vector-based vaccine candidates.…”

Section: Trial Design and Participantsmentioning

confidence: 99%

“… 4 With only one exception, all of these vaccines require two injections to achieve the desired immune response. By comparison, replicating viral vector vaccine candidates for SARS-CoV-2 are in earlier stages of clinical development, 5 and have the potential to be effective with a single injection. V591 is a live, attenuated, recombinant measles vector-based vaccine encoding a stabilised SARS-CoV-2 spike protein.…”

Section: Introductionmentioning

confidence: 99%

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Safety and immunogenicity of the measles vector-based SARS-CoV-2 vaccine candidate, V591, in adults: results from a phase 1/2 randomised, double-blind, placebo-controlled, dose-ranging trial

Vanhoutte

Wiedmann

et al. 2022

eBioMedicine

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Background We report on the safety and immunogenicity of V591, a measles vector-based SARS-CoV-2 vaccine candidate. Methods In this multicentre, randomised, placebo-controlled, double-blind, phase 1/2 trial, healthy adults with no history of COVID-19 disease were assigned to intramuscular injection of V591 or placebo (4:1 ratio). In part 1, younger adults (18-55 years) received V591 median tissue culture infectious dose (TCID 50 )-levels of 1×10 5 or 1×10 6 or placebo, 56 days apart. In part 2, younger and older (>55 years) adults received a single dose of one of four (10 4 /10 5 /10 6 /10 7 ) or one of two (10 5 /10 6 ) V591 TCID 50 levels, respectively, or placebo. Primary outcome: safety/tolerability. Secondary outcome: humoral immunogenicity. ClinicalTrials.gov: NCT04498247. Findings From August–December 2020, 444 participants were screened and 263 randomised (210 V591; 53 placebo); 262 received at least one and 10 received two doses of V591 or placebo. Adverse events were experienced by 140/209 (67.0%) V591 dose-group participants and 37/53 (69.8%) placebo-group participants following injection 1; most frequent were fatigue (57 [27.3%] vs 20 [37.7%]), headache (57 [27.3%] vs 19 [35.8%]), myalgia (35 [16.7%] vs 10 [18.9%]), and injection-site pain (35 [16.7%] vs 4 [7.5%]). No deaths nor vaccine-related serious adverse events occurred. At Day 29, no anti-SARS-CoV-2 spike serum neutralising antibody and IgG-responses were identified in placebo or the three lower V591 dose-groups; responses were detected with V591 1×10 7 TCID 50 , although titres were lower than convalescent serum. Interpretation V591 was generally well tolerated, but immunogenicity was insufficient to warrant continued development. Funding Merck Sharp & Dohme, Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

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Section: Trial Design and Participantsmentioning

confidence: 99%

Section: Trial Design and Participantsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Safety and immunogenicity of the measles vector-based SARS-CoV-2 vaccine candidate, V591, in adults: results from a phase 1/2 randomised, double-blind, placebo-controlled, dose-ranging trial

Vanhoutte

Wiedmann

et al. 2022

eBioMedicine

View full text Add to dashboard Cite

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“…There are studies that have shown the effect of strategies to control the COVID-19 pandemic in the dental field (10), in hospital (11) and in long-term care facilities (LTCFs) (12), by reducing social mixing (13), pertaining to the laboratory-confirmed interval (14) and diagnosis and treatment of patients with cancer (15) during the pandemic. Furthermore, pharmacological (16) and behavioural strategies (17) for the prevention of COVID-19 and the prevention of the same through contact tracing, screening, quarantine, and isolation (18) have also been studied in several research studies. However, there is a distinct lack of study that shows the steps taken by the GoI to prevent the spread of COVID-19 in India.…”

Section: Introductionmentioning

confidence: 99%

Strategies for COVID-19 Epidemiological Surveillance in India: Overall Policies Till June 2021

Ghosh

Saha

Sarkar

et al. 2021

Front. Public Health

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Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has gripped the entire world, almost paralysing the human race in its entirety. The virus rapidly transmits via human-to-human medium resulting in a massive increase of patients with COVID-19. In order to curb the spread of the disease, an immediate action of complete lockdown was implemented across the globe. India with a population of over 1.3 billion was not an exception and took the challenge to execute phase-wise lockdown, unlock and partial lockdown activities. In this study, we intend to summarise these different phases that the Government of India (GoI) imposed to fight against SARS-CoV-2 so that it can act as a reference guideline to help controlling future waves of COVID-19 and similar pandemic situations in India.

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“…Dysregulated release of inflammatory products is a feature of this disease, leading to organ failure and acute respiratory distress syndrome [1]. Hence, clinical trials on immune-based medications that suppress hyperinflammation are being conducted for their use as a treatment for COVID-19 [2]. Among these medications, administering convalescent plasma (CP), which is obtained by extracting blood plasma from donors who have recovered from COVID-19, has been shown to significantly improve the clinical outcomes of hospitalized patients with the disease [3].…”

Section: Introductionmentioning

confidence: 99%

Compassionate Use of GC5131 (Hyperimmunoglobulin) Therapy in Critically Ill Patients Diagnosed with COVID-19: A Case Series and Review of Literature

Choi

Hwang

Kwon

2021

Viruses

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Presently, the use of convalescent plasma and hyperimmunoglobulin obtained from individuals who have recovered from coronavirus disease 2019 (COVID-19) has proved to potentially provide passive antibody-based immunity, thereby leading to several clinical trials to develop an immune-based COVID-19 treatment. However, the therapeutic efficacy of hyperimmunoglobulin in critically ill patients with COVID-19 remains unknown. On 23 October 2020, we first administered GC5131 in a compassionate-use program to critically ill patients at the Kyungpook National University, Chilgok Hospital, Korea. Since then, five more critically ill patients were treated with GC5131 in this compassionate-use program in our hospital up until 17 December 2020. We retrospectively reviewed the clinical responses of six critically ill patients diagnosed with COVID-19 who received the hyperimmunoglobulin concentrate, GC5131, which was produced by the Green Cross Corporation. After the administration of GC5131, five patients died due to an exacerbation of COVID-19 pneumonia. GC5131 was ineffective when administered to critically ill patients with COVID-19. Nevertheless, we propose that to expect a therapeutic effect from GC5131, it should be administered as early as possible to avoid the excessive inflammatory response phase in patients with severe and advanced COVID-19 infection. This step was difficult to achieve in the real world due to the time required for decision making and the process of the compassionate-use program.

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Pharmacological strategies to prevent SARS-CoV-2 infection and treat the early phases of COVID-19

Cited by 22 publications

References 46 publications

Safety and immunogenicity of the measles vector-based SARS-CoV-2 vaccine candidate, V591, in adults: results from a phase 1/2 randomised, double-blind, placebo-controlled, dose-ranging trial

Safety and immunogenicity of the measles vector-based SARS-CoV-2 vaccine candidate, V591, in adults: results from a phase 1/2 randomised, double-blind, placebo-controlled, dose-ranging trial

Strategies for COVID-19 Epidemiological Surveillance in India: Overall Policies Till June 2021

Compassionate Use of GC5131 (Hyperimmunoglobulin) Therapy in Critically Ill Patients Diagnosed with COVID-19: A Case Series and Review of Literature

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