HH-120 / Huahui Health - LARVOL DELTA

Non-Intrusive Monitoring and Detection of Mobility Loss in Older Adults Using Binary Sensors. (PubMed, Sensors (Basel)) - "(2) The study utilized publicly available datasets (CASAS Aruba and HH120) containing annotated activity data recorded from binary sensors installed in residential environments...(4) The study argues that non-intrusive binary sensors, combined with lightweight forecasting models and fuzzy inference, may provide a practical and scalable solution for detecting mobility anomalies in older adults. Although performance can be further enhanced through improved data preprocessing, predictive modeling, and anomaly threshold tuning, the proposed system effectively addresses key limitations of existing mobility assessment approaches."

Journal

HH-120 Nasal Spray for Post-exposure Prevention of SARS-CoV-2 (clinicaltrials.gov) - P3 | N=1200 | Enrolling by invitation | Sponsor: Huahui Health | Recruiting ➔ Enrolling by invitation | Trial completion date: Jun 2024 ➔ Apr 2026 | Trial primary completion date: Dec 2023 ➔ Dec 2025

Enrollment status • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study To Assess The Efficacy and Safety of HH-120 Nasal Spray for the Treatment of Mild COVID-19 (clinicaltrials.gov) - P2 | N=200 | Completed | Sponsor: Huahui Health | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Nasal spray of an IgM-like ACE2 fusion protein HH-120 prevents SARS-CoV-2 infection: Two investigator-initiated postexposure prophylaxis trials. (PubMed, J Med Virol) - "In Part 2 (76 participants), the infection rates were 17.1% (HH-120) versus 30.4% (placebo), symptomatic infection rates were 7.5% versus 27.3%, with a RRR of 43.8% and 72.5%, respectively. No HH-120-related serious adverse effects were observed. The HH-120 nasal spray used as PEP was safe and effective in preventing laboratory-confirmed and symptomatic SARS-CoV-2 infection."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in COVID-19 Patients (clinicaltrials.gov) - P=N/A | N=111 | Completed | Sponsor: Beijing Ditan Hospital | Recruiting ➔ Completed | N=77 ➔ 111 | Trial completion date: Jun 2023 ➔ Jan 2023

Enrollment change • Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled HH-120 Aerosol in Healthy Volunteers (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Huahui Health | Recruiting ➔ Completed

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

A Study to Evaluate the Safety and Pharmacokinetics of HH-120 Nasal Spray in Healthy Volunteers (clinicaltrials.gov) - P1 | N=62 | Completed | Sponsor: Huahui Health | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

HH-120 Nasal Spray for Post-exposure Prevention of SARS-CoV-2 (clinicaltrials.gov) - P3 | N=1200 | Recruiting | Sponsor: Huahui Health | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Assess the Safety, Tolerability and Preliminary Efficacy of HH-120 for the Treatment of COVID-19 (clinicaltrials.gov) - P1 | N=37 | Completed | Sponsor: Huahui Health

New P1 trial • Infectious Disease • Novel Coronavirus Disease

An IgM-like inhalable ACE2 fusion protein broadly neutralizes SARS-CoV-2 variants. (PubMed, Nat Commun) - "Our study presents a meaningful advancement in the inhalation delivery of large biologics like HH-120 (molecular weight (MW) ~ 1000 kDa) and demonstrates that HH-120 can serve as an efficacious, safe, and convenient agent against SARS-CoV-2 variants. Finally, given the known role of ACE2 in viral reception, it is conceivable that HH-120 has the potential to be efficacious against additional emergent coronaviruses."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Nasal spray of an IgM-like ACE2 fusion protein HH-120 accelerates SARS-CoV-2 clearance: A single-center propensity score-matched cohort study. (PubMed, J Med Virol) - "The HH-120 nasal spray showed a favorable safety profile and promising antiviral efficacy in SARS-CoV-2-infected subjects. The results from this study warrant further assessment of the efficacy and safety of the HH-120 nasal spray in large-scale randomized controlled clinical trials."

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

HH-120 Nasal Spray for Post-exposure Prevention of SARS-CoV-2 (clinicaltrials.gov) - P3 | N=1200 | Not yet recruiting | Sponsor: Huahui Health

New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Assess the Efficacy of HH-120 Nasal Spray for Prevention of SARS-CoV-2 Infection in Adult Close Contacts of Individuals Infected With SARS-CoV-2 (clinicaltrials.gov) - P=N/A | N=281 | Completed | Sponsor: Beijing Ditan Hospital

New trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate the Safety and Pharmacokinetics of HH-120 Nasal Spray in Healthy Volunteers (clinicaltrials.gov) - P1 | N=62 | Active, not recruiting | Sponsor: Huahui Health

New P1 trial • Infectious Disease • Novel Coronavirus Disease

A Study of HH-120 Nasal Spray in Close Contacts of Those Diagnosed With COVID-19 (clinicaltrials.gov) - P=N/A | N=14 | Completed | Sponsor: Beijing Ditan Hospital

New trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study To Assess The Efficacy and Safety of HH-120 Nasal Spray for the Treatment of Mild COVID-19 (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Huahui Health

New P2 trial • Infectious Disease • Novel Coronavirus Disease

A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in COVID-19 Patients (clinicaltrials.gov) - P=N/A | N=77 | Recruiting | Sponsor: Beijing Ditan Hospital

New trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled HH-120 Aerosol in Healthy Volunteers (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Huahui Health | Not yet recruiting ➔ Recruiting | Trial completion date: May 2022 ➔ Sep 2022

Enrollment open • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases