Other substances

Daclatasvir

An anti-hepatitis C virus drug.

Phase of research

Potential treatment - clinical evidence

How it helps

Antiviral

Drug status

Used to treat other disease

5
 Supporting references
0
 Contradictory references
18
 AI-suggested references
8
 Clinical trials

General information

Daclatasvir is a drug used for treatment of hepatitis C virus (HCV) infection (e. g. in combination with Sofosbuvir). It binds to a HCV structural protein; however, its mechanism of action is not well understood (NCIt). It might disrupt the structure of the SARS-CoV-2 RNA (Sacramento et al., 2021).

Daclatasvir on Drugbank
Daclatasvir on PubChem
Daclatasvir on Wikipedia

Marketed as

DAKLINZA (DACLATASVIR DIHYDROCHLORIDE)

 

Structure image - Daclatasvir

CC(C)[C@@H](C(=O)N1CCC[C@H]1C2=NC=C(N2)C3=CC=C(C=C3)C4=CC=C(C=C4)C5=CN=C(N5)[C@@H]6CCCN6C(=O)[C@H](C(C)C)NC(=O)OC)NC(=O)OC

Supporting references

Link Tested on Impact factor Notes Publication date
Predicting commercially available antiviral drugs that may act on the novel coronavirus (2019-nCoV), Wuhan, China through a drug-target interaction deep learning model
Preprint In silico 		in silico Feb/02/2020
The in vitro antiviral activity of the anti-hepatitis C virus (HCV) drugs daclatasvir and sofosbuvir against SARS-CoV-2
Preprint 		HuH-7 and Calu-3 cells Jun/16/2020
Sofosbuvir and daclatasvir compared with standard of care in the treatment of patients admitted to hospital with moderate or severe coronavirus infection (COVID-19): a randomized controlled trial
Severe severity Small molecule Non-randomized controlled open trial Moderate severity 		Patients 5.44

The fixed-dose with sofosbuvir significantly shortened median duration of hospitalization versus standard care. Sample size: 33 + 33 control. Dosage: 400 mg sofosbuvir and 60 mg daclatasvir in addition to standard care for 14 days. Endpoint: Clinical recovery within 14 days of enrolment (primary).

 Aug/19/2020
The impact of sofosbuvir/daclatasvir or ribavirin in patients with severe COVID-19
Small molecule Non-randomized controlled open trial 		Patients 5.44

In a fixed-dose with sofosbuvir significantly reduced time to clinical improvement and caused less side effects when compared to ribavirin treatment. Sample size: 35 + 27 (ribavirin arm). Dosage: 400 mg sofosbuvir and 60 mg daclatasvir twice a day for a maximum of 14 days.

 Aug/18/2020
Structure-based virtual screening of phytochemicals and repurposing of FDA approved antiviral drugs unravels lead molecules as potential inhibitors of coronavirus 3C-like protease enzyme
3CLpro Small molecule In silico 		in silico 3.82

Predicted to inhibit the SARS-CoV-2 3C-like protease.

 Jul/17/2020

AI-suggested references

Link Publication date
Efficacy of combined Sofosbuvir and Daclatasvir in the treatment of COVID-19 patients with pneumonia: a multicenter Egyptian study.
Jul/15/2021
Evaluation of the Binding Affinity of Anti-Viral Drugs against Main Protease of SARS-CoV-2 through a Molecular Docking Study.
Mar/01/2022
Computational identification of host genomic biomarkers highlighting their functions, pathways and regulators that influence SARS-CoV-2 infections and drug repurposing.
Mar/11/2022
Investigating the binding affinity, interaction, and structure-activity-relationship of 76 prescription antiviral drugs targeting RdRp and Mpro of SARS-CoV-2
May/20/2020
Evaluation of the efficacy of sofosbuvir plus daclatasvir in combination with ribavirin for hospitalized COVID-19 patients with moderate disease compared with standard care: a single-centre, randomized controlled trial
Aug/20/2020
In vitro antiviral activity of the anti-HCV drugs daclatasvir and sofosbuvir against SARS-CoV-2, the aetiological agent of COVID-19
Apr/22/2021
Sofosbuvir/daclatasvir regimens for the treatment of COVID-19: an individual patient data meta-analysis
Jul/28/2021
A bacterial artificial chromosome (BAC)-vectored noninfectious replicon of SARS-CoV-2
Jul/26/2020
Sofosbuvir terminated RNA is more resistant to SARS-CoV-2 proofreader than RNA terminated by Remdesivir
Jul/06/2020
Drug repurposing for identification of potential inhibitors against SARS-CoV-2 spike receptor-binding domain: An in silico approach
Sep/22/2021
Asunaprevir, a Potent Hepatitis C Virus Protease Inhibitor, Blocks SARS-CoV-2 Propagation
Apr/20/2021
Identification of host transcriptome-guided repurposable drugs for SARS-CoV-1 infections and their validation with SARS-CoV-2 infections by using the integrated bioinformatics approaches
Apr/07/2022
Target-Centered Drug Repurposing Predictions of Human Angiotensin-Converting Enzyme 2 (ACE2) and Transmembrane Protease Serine Subtype 2 (TMPRSS2) Interacting Approved Drugs for Coronavirus Disease 2019 (COVID-19) Treatment through a Drug-Target Interacti
Nov/18/2020
Evaluation of the effect of sofosbuvir and daclatasvir in hospitalized COVID-19 patients: a randomized double-blind clinical trial (DISCOVER)
Nov/28/2021
Identification of SARS-CoV-2 inhibitors targeting Mpro and PLpro using in-cell-protease assay
Feb/25/2022
Molecular modelling studies unveil potential binding sites on human serum albumin for selected experimental and in silico COVID-19 drug candidate molecules
Apr/19/2022
Computational estimation of potential inhibitors from known drugs against the main protease of SARS-CoV-2
May/12/2021
Efficacy and safety of sofosbuvir plus daclatasvir or ravidasvir in patients with COVID-19: A randomized controlled trial
Mar/26/2021

Clinical trials

ID Title Status Phase Start date Completion date
NCT04561063 COVID-19 Prophylaxis South Africa (COVER HCW) Recruiting Phase 2 Dec/08/2020 Feb/28/2022
  • Alternative id - EZ-SS-025
  • Interventions - Drug: Nitazoxanide|Drug: Sofosbuvir/Daclatasvir
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, Gauteng, South Africa|Sunnyside Office Park, Johannesburg, Gauteng, South Africa
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 1950
  • Age - 18 Years to 99 Years   (Adult, Older Adult)
  • Outcome measures - Number of SARS-CoV-2 infections|Duration of symptoms|Maximum score on WHO Ordinal Scale|Time to onset of SARS-CoV-2 infection|Number of symptomatic SARS-CoV-2 infections|Number of asymptomatic SARS-CoV-2 infections|Peak score on modified Flu PRO
NCT04443725 Efficacy and Safety of Anti HCV Drugs in the Treatment of COVID-19 Not yet recruiting Phase 2|Phase 3 Jul/01/2020 Dec/01/2020
  • Alternative id - CUKA-003
  • Interventions - Drug: Hydroxychloroquine , Sofosbuvir, daclatasvir|Drug: Standard of care treatment
  • Study type - Interventional
  • Study results - No Results Available
  • Locations -
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 100
  • Age - 18 Years to 65 Years   (Adult, Older Adult)
  • Outcome measures - Virological cure
NCT04497649 Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients Recruiting Phase 2|Phase 3 Jul/01/2020 Apr/10/2021
  • Alternative id - Tanta sofosbuvir covid
  • Interventions - Drug: Sofosbuvir|Drug: Daclatasvir
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Cairo and Tanta Universitities, Tanta, Egypt
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 100
  • Age - Child, Adult, Older Adult
  • Outcome measures - Number of patients with improvement or mortality
NCT04460443 Sofosbuvir in Treatment of COVID 19 Recruiting Phase 2|Phase 3 Aug/01/2020 Aug/31/2021
  • Alternative id - sofosbuvir
  • Interventions - Drug: sofosbuvir|Drug: Sofosbuvir ledipsavir|Drug: Daclatasvir
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Sherief Abd-Elsalam, Tanta, Egypt
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 60
  • Age - Child, Adult, Older Adult
  • Outcome measures - Number of patients with response to treatment
NCT04773756 Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt Completed Phase 4 Nov/01/2020 Dec/12/2020
  • Alternative id - 0305032
  • Interventions - Drug: Sofosbuvir 400 MG/ Daclatasvir 60mg
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Amr Aly Abd elmoety, Alexandria, Egypt
  • Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 54
  • Age - 12 Years to 90 Years   (Child, Adult, Older Adult)
  • Outcome measures - evaluate the combined effect of Sofosbuvir and Daclatasvir in treatment of patients with mild-moderate Covid-19.
NCT04535869 Efficacy and Safety of Direct Anti HCV Drugs in the Treatment of SARS-COV-2 (COVID-19) Recruiting Phase 3 Dec/28/2020 Sep/03/2021
  • Alternative id - MS.20.08.1214
  • Interventions - Drug: Sofosbuvir 400 MG plus Daclatasvir 200mg
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Mansoura Faculty of Medicine, Mansoura, Dakahlyia, Egypt
  • Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 50
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - rate of virological cure by Rt -PCR for COVID -19using the triple therapy as compared to standard treatment|resolution of pneumonia BY high resolution Computed tomography
NCT04532931 COVID-19 Treatment in South Africa Completed Phase 2 Sep/03/2020 Aug/23/2021
  • Alternative id - SP-PA-COV-202
  • Interventions - Other: Standard of care (Paracetamol)|Drug: Artesunate-amodiaquine|Drug: Pyronaridine-artesunate|Drug: Favipiravir plus Nitazoxanide|Drug: Sofosbuvir/daclatasvir
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Ezintsha, Wits Reproductive Health & HIV Institute University of the Witwatersrand, Johannesburg, South Africa
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 192
  • Age - 18 Years to 65 Years   (Adult, Older Adult)
  • Outcome measures - Incidence of SARS-CoV-2 clearance|Time to clearance of nasal SARS-CoV-2|Median quantity of SARS-CoV-2|Proportion of days with fever after randomization|Proportion of days with respiratory symptoms after randomization|FLU-PRO© Plus|Serious adverse events|Adverse events resulting in treatment discontinuation|Adverse events considered related to the investigational products|LRTI|Maximum score on WHO Ordinal Scale for Clinical Improvement during study participation|Cumulative incidence of hospitalization|Days of hospitalization|Cumulative incidence of mortality
NCT04468087 Antiviral Agents Against COVID-19 Infection Active, not recruiting Phase 2|Phase 3 Feb/15/2021 Dec/31/2022
  • Alternative id - REVOLUTIOn
  • Interventions - Drug: Atazanavir|Drug: Daclatasvir 60 mg|Drug: Sofusbuvir + Daclastavir 60 mg|Drug: Placebo Atazanavir|Drug: Placebo Daclatasvir 60 mg|Drug: Placebo Sofusbuvir + Daclatasvir 60 mg
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hospital do Coracao, Sao Paulo, SP, Brazil
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 256
  • Age - 18 Years to 90 Years   (Adult, Older Adult)
  • Outcome measures - Phase II first step: Change in the slope of SARS-COV 2 viral load|Phase II second step: Change in the slope of SARS-COV 2 viral load|Phase III: Number of free days from respiratory support
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